The Cancer Research Department at the Coborn Cancer Center opens new clinical trials on a regular basis. Please contact the research staff at (320) 229-4907 for information on these or additional studies that may be open and available to treat, control or prevent cancer. A sample of cancer research trials currently open to enrollment at the Coborn Cancer Center is listed below.

Treatment Trials

Breast	Head and Neck	Lung	Myeloma
Central Nervous System	Hematology	Lymphoma	Prostate
Colon and Rectal	Leukemia	Melanoma	Renal
Esophagus or Gastric

Breast

N0735 / Phase II Trial of Albumin-Bound Paclitaxel in Combination with Gemcitabine and Bevacizumab in Patient with Metastatic Breast Cancer

The purpose of this research study is to find out what effects that the combination of albumin-bound paclitaxel plus gemcitabine and bevacizumab has on metastatic breast cancer (breast cancer that has spread to other parts of your body).

Gemcitabine, albumin-bound paclitaxel and bevacizumab are approved by the FDA to treat some types of cancer, including breast cancer.

CALGB 40502 / A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

The purpose of this study is to compare the anticancer effects and side effects of these three different chemotherapy drugs given on a weekly schedule in combination with bevacizumab. In this study the patient will receive treatment for 3 out of every 4 weeks with one of the following chemotherapy drugs: paclitaxel, nab-paclitaxel, or ixabepilone. The patient will also receive bevacizumab every two weeks regardless of which chemotherapy drug the patient receives.

N063D / ALTTO Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer

This purpose of this research study is to:
• Find out what effects the study treatment has on breast cancer.
• Compare four different study treatment combinations to see if one is better
• Find out what effects this study has on quality of life.

Because of recent research by NCCTG, the standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin®). However, not all patients with HER2+ breast cancer do better with trastuzumab, so investigators are trying to find out why. GW572016 (lapatinib, brand name: Tykerb®) is a new drug that is taken every day by mouth. Lapatinib is considered “investigational” in this study. “Investigational” means that the FDA has not approved lapatinib as a treatment for early breast cancer.

CALGB / 40503 Endocrine Therapy in Combination with Anti-VEGF Therapy - A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab For Women with Hormone Receptor-Positive Advanced Breast Cancer

The purpose of this study is to determine whether the addition bevacizumab to standard endocrine therapy can improve the effectiveness of endocrine therapy alone. This study will compare the effects of bevacizumab in combination with endocrine therapy with the effects of endocrine therapy alone, to see which is better.

S0500 / A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-up Assessment

The purpose of this experimental study is to find out if the CellSearch™ blood test, which identifies tumor cells in the blood, can predict survival outcome in patients with metastatic breast cancer. These tumor cells are called circulating tumor cells (CTCs). The CellSearch™ blood test may allow doctors to tell if current chemotherapy is not working before the patient shows signs that that the cancer is getting worse. This is based upon a prior study that showed that most women with high numbers of CTCs had worsening of their breast cancer within 1-3 months. In this prior study, increase in the size of a tumor or spread of cancer in the body was determined by standard clinical tests such as physical examinations, x-rays and scans, and not by the CellSearch™ blood test. This study will test whether switching to another form of treatment based upon the results of the CellSearch™ blood test helps people live longer. In addition, this study will be used to further confirm results of the prior study, which showed that patients with < 5 CTCs before they begin treatment are more likely to live longer than those with ≥ 5 CTCs.

S0307 / Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. "Bisphosphonates" are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them.

E1105 / A Randomized Phase III Double-Blind Placebo-Controlled Trial of First Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over Expressing Metastatic Breast Cancer

This research is being done in order to develop more effective treatments for patients with breast cancer that has spread (metastatic) and that has high levels of a protein called HER-2/NEU in their tumor. The standard treatment, chemotherapy plus trastuzumab (HerceptinTM) has been shown to help control the type of metastatic breast cancer that expresses a protein called HER-2/NEU. However, in many cases the tumor eventually grows back. The purpose of this study is to see if adding the drug bevacizumab to the currently accepted therapy of trastuzumab and chemotherapy causes a delay in the progression of your tumor compared to trastuzumab and chemotherapy alone.

C40101 / Cyclophosphamide and Doxorubicin (CA x 4 cycles) versus Paclitaxel (4 cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study

The purpose of this study is to compare the effectiveness of the standard adjuvant chemotherapy CA with the chemotherapy drug paclitaxel. In addition, we will learn more about the side effects of each treatment, and compare them with each other, in order to measure the effectiveness and tolerability of the treatments.

PACCT-1 / Program for the Assessment of Clinical Cancer Tests (PACCT-1):
Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

The purpose of this study is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy, and to confirm that patients who have Oncotype DX Recurrence Score of < 10 have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence).

S0221 / Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

The main purpose of this study is to compare the effects of four different treatments (or “regimens”) for breast cancer. All of these treatments include essentially the same drugs given in different ways and on different schedules. All of the treatments use standard, commercially available medicines that are known to be effective for treating breast cancer.

B-39/RTOG 0413 / A Randomized Phase III Study of Conventional Whole Breast
Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast.

Central Nervous System (Brain)

N057K / Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolmide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma

The purpose of this research study is to:
• Add everolimus to the standard treatment temozolomide and radiation, to see if this addition makes the standard treatment better. Everolimus helps to stop signals that cause tumors to grow. Everolimus is investigational and is currently not approved for use in brain tumors.
• Test the safety of the everolimus when given in combination with temozolomide.

N0776 / A Phase II Trial of Avastin in Combination with Sorafenib in Recurrent Glioblastoma Multiforme

The purpose of this research study is to:
• Find out what effects the combination of Avastin® and sorafenib have on Glioblastoma multiforme cancer.
• Find out if MRI testing can help tell the investigators what kind of response the patient might have to the treatment.
• Find out if there are individual differences and/or tumor characteristics that will affect response to treatment.
• See how treatment affects the quality of life.

The use of Avastin® and sorafenib in this study is considered investigational.

RTOG 0825 / Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma

The purpose of this study is to determine whether the addition of bevacizumab to the standard chemoradiation will further improve the outcome. This study will find out what effects, good and/or bad, this change in treatment has on the tumor compared with standard treatment. Bevacizumab has not been approved by the US Food and Drug Administration for the treatment of glioblastoma.

N0572 Phase I/II Trial of Sorafenib and CCI-779 in Patients with Recurrent Glioblastoma

This study is being done:
• To find out what effects sorafenib and CCI-779 have on brain tumors
• To compare the response to sorafenib and CCI-779 with laboratory studies of the patients blood cells and tumor tissues
• To look at sorafenib and CCI-779’s ability to slow down the growth of brain tumors.

Sorafenib and CCI-779 are experimental drugs not yet approved by the Food and Drug Administration.

N0779 Phase II Study of Varinostat (SAHA) in Combination with Bortezomib (PS-341) in Patients with Recurrent Glioblastoma Multiforme

The purpose of this research study is to:
• find out what effects vorinotat and bortezomib in combination have on the patient and the patients brain tumor
• look at vorinostat and bortezomib’s ability to slow down the growth of the tumor

Vorinostat is a Food and Drug Administration approved drug indicated for the treatment of cutaneous T-cell lymphoma, a cancer of blood cells that infiltrates the skin. Bortezomib is an FDA-approved drug used in the treatment of multiple myeloma, a cancer of one of the bone marrow cells. The combination of vorinostat and bortezomib in this setting is investigational.

Esophagus or Gastric (Stomach)

There are no current esophagus/gastric studies.

Colon and Rectal

C80405 / Phase III Trial of Inrinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab or Cetuximab (C225) for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

This study is being done to evaluate the effects of different regimens of chemotherapy. There are two common combinations of chemotherapy drugs: One uses 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX;”the other combination uses 5-FU, leucovorin, and irinotecan, this combination is also called “FOLFIRI.” At the present time, the Food and Drug Administration (FDA) has approved each of these as treatment for colon or rectal cancer.

The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients.

Cetuximab is approved by the FDA for the treatment of colorectal cancer in patients who have developed progressive cancer following the use of irinotecan. Recent studies, however, have shown that people who have a mutation (an abnormality) in a gene in their tumor tissue called K-ras do not appear to benefit from treatment with cetuximab or other similar drugs. Another recent study has shown that adding cetuximab to a regimen of bevacizumab and chemotherapy does not appear to help patients with colorectal cancer, however, that study included patients who had K-ras mutations in their tumors.

The purpose of this study is to determine whether cetuximab plus chemotherapy is better than bevacizumab with chemotherapy in patients who do not have K-ras mutations in their tumor tissue.

E5202 / A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

The purpose of this study is to determine whether specific biological features (often called tumor markers or markers) seen in tests done on a tumor (found in the colon) can be used to predict recurrence of tumors in patients with stage II colon cancer. Also to compare the effects of a combination of chemotherapy drugs, when given with and without a new drug, bevacizumab, on patients with stage II colon cancer at high-risk for recurrence.

R-04 / A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum

This study is being done to see if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks the patient is receiving radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given continuously into the vein during the weeks the patient is receiving radiation therapy.

N0147 / A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

This study is being done in patients who have had surgery for colon cancer. The study is being done to:
• Find out if adding cetuximb to FOLFOX (a combination of the 3 drugs oxaliplatin, leucovorin and 5-fluorouracil) increases the effectiveness of FOLFOX in preventing colon cancer from coming back.
• See whether patients get better results in one of these groups.
• Compare the side effects in the two groups of patients in the study.
• We will look at markers in tissue or blood specimens obtained from you to determine whether these markers can be used to predict whether your tumor responds to chemotherapy or the chance that your cancer will come back. These studies are for research purposes and have not been accepted into routine medical practice.

As of June 2008 it became apparent that a change within the genes of the tumor can better help predict who may be likely to benefit from cetuximab. Changes in a gene called KRAS have been shown to greatly lessen or prevent any benefit from the use of cetuximab. Based on this new finding this trial will now enroll and treat only patients that have the normal (wild-type) version of the KRAS gene.

Prostate

E3805 / CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

The purpose of this study is to evaluate a new way of treating patients with prostate cancer. In Arm A, the patient will receive docetaxel chemotherapy both at the time of starting hormonal therapy and later when/if the hormonal therapy is no longer working per the doctor’s decision. In Arm B, patients only get chemotherapy when/if the hormonal therapy is no longer working per the doctor’s decision. We are doing the study to see if there is a benefit to giving chemotherapy at the beginning.

A6181120 / A Multicenter, Randomized, Double-blind, Phase 3 Study of Sunitinib plus Prednisone versus Prednisone in Patients with Progressive Metastatic Hormone-Refractory Prostate Cancer After Failure of a Docetaxel-based Chemotherapy Regimen

The purpose of this study is to determine whether sunitinib, in combination with prednisone, is safe and efficacious when compared with prednisone alone in subjects with progressive mHRPC that has failed one prior chemotherapy treatment with docetaxel.

RTOG 0621 / Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer in Patients Post Prostatectomy: A Phase II Trial

The purpose of this study is to find out what effects a combination of local (radiation therapy) and systemic (hormonal therapy and chemotherapy) treatments has on the risk of recurrence of prostate cancer.

S0421 / Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

The purpose of this study is to compare the effects of the combination of docetaxel and prednisone plus atrasentan against the combination of docetaxel and prednisone plus placebo on prostate cancer to see which is better. This research is being done because many people think that the new combination of docetaxel and prednisone plus the investigational drug atrasentan may be better than the commonly used combination of docetaxel and prednisone alone, but these two treatments have not been compared.  Atrasentan is an investigational drug.  It has not been approved by the FDA for commercial use.  We do not know which of these two treatments is better.

RTOG 0534 / Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in Prostatic Cancer Patients with a Rising PSA After Radical Prostatectomy

The purpose of this study is to compare the effects of three treatment methods on participants and their cancer. 

There are 3 treatment groups in this study:
1)   Patients who receive radiation therapy to the prostate bed only;
2)   Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed;
3)   Patients who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes.

CALBG 90203 / Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer

The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove your prostate) with radical prostatectomy alone to see which is better.

RTOG 0415 / A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients With Favorable-Risk Prostate Cancer

The purpose of this study is to compare the effects of the standard dose of radiation therapy (41 treatments over 8 weeks) with a higher daily dose (experimental) of radiation (28 treatments over 5 and a half weeks) to see if the effects of the treatments are similar.

Renal (Kidney)

E2804 / The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma

The purpose of this study is to compare the effects of several different treatments on metastatic renal cell carcinoma. In this study, you will get one regimen for as long as it prevents growth of your cancer.

Based on laboratory experiments, we believe that combinations of two anti-cancer treatments may be superior to any one therapy alone. This study is designed to determine which of the four drug regimens should be tested in later clinical trials. You will be assigned to one of the following experimental arms: Arm A (bevacizumab alone); Arm B (bevacizumab and temsirolimus); Arm C (bevacizumab and sorafenib); and Arm D (temsirolimus and sorafenib).

E2805 / ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

The purpose of this study is to determine if either Sunitinib or Sorafenib can prevent recurrence of kidney cancer and to compare the effects of the Sunitinib and the Sorafenib with placebo on kidney cancer to see which is better. It is not known whether the benefits of taking either sunitinib or sorafenib will outweigh the risks.

Lymphoma

N0682 / A Phase II Clinical Trial of Denileukin Diftitox in Combination with Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin’s Lymphoma

This research study is being done to find out what effect, a combination of two drugs has follicular B-cell non-Hodgkin’s lymphoma.

Lung

Non Small Cell Lung

N0626 Phase II Randomized Study of Pemetrexed with Sorafenib versus Pemetrexed Alone as Second Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer

The purpose of this research study is to:
• compare the effects of using sorafenib in combination with pemetrexed versus pemetrexed alone, on non-small cell lung cancer (NSCLC).
• find out if there are individual differences and/or tumor characteristics that will affect response to treatment.

Sorafenib is an FDA-approved drug for the treatment of kidney cancer. Pemetrexed is a standard chemotherapy drug that is used in patients with this type of lung cancer that did not respond to or that progressed after a first course of treatment.

N0723 MARVEL: Marker Validation of Erlotinib in Lung Cancer - A Phase III Biomarker Validation study of Second-line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) randomized to Pemetrexed Versus Erlotinib

The purpose of this research study is to:
• Find out if a test called fluorescent in-situ hybridization (FISH) can help doctors decide whether erlotinib or pemetrexed will work better for patients with non-small cell lung cancer (NSCLC).
• Find out if there are other individual differences and/or tumor characteristics that will affect response to treatment using either erlotinib or pemetrexed.

Erlotinib is an FDA-approved drug for the treatment of lung cancer that has progressed after chemotherapy. Pemetrexed is a standard chemotherapy drug that is also approved by the FDA for the treatment of lung cancer that has progressed after initial treatment with chemotherapy combinations. Therefore, patients whose tumors progress after chemotherapy combinations can get either erlotinib or pemetrexed. The main purpose for this study is to find out whether the FISH test can help doctors to better predict whether patients with previously treated non-small cell lung cancer will be more likely to benefit from erlotinib or pemetrexed.

RTOG 0617 / A Randomized Phase III Comparison of Standard Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/ Paclitaxel +/- Cetuximab in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer.

One purpose of this study is to compare the effects of high-dose radiation therapy and chemotherapy with standard dose radiation therapy and chemotherapy on lung cancer to find out which is better. In this study, you will get either the high-dose or the standard-dose radiation therapy. The high-dose radiation therapy is considered experimental in this study. Everyone will get the chemotherapy with the same drug combination and schedule, consisting of paclitaxel and carboplatin. In addition, this study will compare the effects of adding cetuximab to radiation and chemotherapy. In this study, you will get either radiation and chemotherapy or radiation, chemotherapy, and cetuximab.

C30607 / Randomized, Phase III, Double Blind Placebo Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

The purpose of this study is to determine whether or not giving a drug called sunitinib after a response to chemotherapy (tumor shrinks or stops growing) will help the tumor continue to shrink, or stay the same. Sunitinib is experimental (investigational) in the treatment of non-small cell lung cancer. Standard treatment of this type of cancer would be to stop chemotherapy treatment after receiving initial therapy.

E1505 / A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer.

Small Cell Lung

There are no current small cell lung studies.

Melanoma

N0775 / A Randomized Phase II Trial of Temozolomide and Avastin or ABI-007/Carboplatin and Avastin in Patients with Unresectable Stage IV Malignant Melanoma

This research study is being done to:
• Find out what effects the combination of study drugs has on melanoma
Group A: Temozolomide and Avastin®.
Group B: Avastin®, ABI-007 and carboplatin.
• Find out what effects the combination of study drugs has on the immune system and the way the tumor grows.

Temozolomide, ABI-007, carboplatin and Avastin® are chemotherapy drugs that are FDA approved to treat certain types of cancer. However, the combinations listed above have not been approved for the treatment of melanoma; so the use of this combination in this study is considered investigational.

E1697 / Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2bN0,T3a-b , T4a-bN0 and T1-4, N1a,2a,3(microscopic) Melanoma.

The purpose of this study is to compare the benefits of treatment with Interferon to no treatment after surgery.

Head and Neck

E1305 / A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck Cancer

The purpose of this study is to compare the effects of the addition of a drug called bevacizumab to the standard chemotherapy to see which works better. We will determine if the combination of standard chemotherapy (cisplatin and docetaxel or cisplatin and 5-FU) and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental. We will determine if the adding bevacizumab to standard therapy produces results that are better than those we would ordinarily expect. Currently, we do not know whether using bevacizumab will be effective. This is a subject of this study. Bevacizumab is approved by the Food and Drug Administration (FDA) for another type of cancer, colorectal cancer, but is not approved for head and neck cancer.

Hematology

E2905 / Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low or Intermediate-1 Risk MDS and Symptomatic Anemia

This study is being done to determine if the combination of treatment with epoetin alfa and lenalidomide is better than lenalidomide alone in improving red blood cell production and in relieving the need for red blood cell transfusions in patients with MDS (myelodysplastic syndrome).

AVIDA / The Vidaza Patient Registry

The AVIDA Registry is an observational study compiling data on the management of patients treated with Vidaza. Vidaza was the first drug approved by the US Food and Drug Administration (FDA) for the treatment of MDS (myelodysplastic syndromes), a group of diseases that affect the bone marrow and blood.

Leukemia

E2902 / Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure or Patients over Age 60 in First Remission

The purpose of this study is to determine how well the experimental drug called Farnesyl Transferase Inhibitor (FTI) R115777 can keep AML in remission and to see what side effects the drug causes.

RC0783 / Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

The purpose of this research study is to learn about the effectiveness and side effects of Pentostatin, Cyclophosphamide, and Rituximab (PCR) with or without a fourth medicine, Avastin®, for previously untreated B-chronic lymphocytic leukemia.

CALGB 10501 / A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Patients Randomized To Early Intervention Versus Observation with Later Treatment in the High Risk Genetic Subset with IgVh Unmutated Disease

The purpose of this study is to determine the best time to begin treatment for patients with CLL that have certain features of their disease that are considered to be high-risk, and to determine whether patients with these high risk features will live longer if treatment is given earlier.

Myeloma

S0777 A Randomized Phase III Trial of Lenalidomide and Low Dose Dexamethasone (LLD) Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant.

The purpose of this study is to compare the effectsof a two-drug combination (CC-5013 [lenalidomide] and low dose dexamethasone, also called "LLD") with a three-drug combination (CC-5013 [lenalidomide], low dose dexamethasone, and a new drug called bortezomib ([Velcade®], also called "BLLD"). CC-5013 (lenalidomide) and bortezomib are both experimental drugs. We are comparing these two different combinations of drugs to evaluate whether they can stop or slow down the progression of cancer, and if so, which one is more effective.

Control Trials

N08C3 / Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patient Receiving Highly Emetogenic Chemotherapy

The purpose of this research study is to compare the effects of gabapentin with standard nausea medications to find out which is better for delayed nausea and vomiting (that which happens 24 hours or later after chemotherapy.

C70604 / A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

The purpose of this study is to compare the effects of less frequent treatment (every 12 weeks) with zoledronic acid (Zometa) compared to standard treatment (every 4 weeks) with zoledronic acid.

RTOG 0614 / A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brian Radiotherapy

The purpose of this study is to compare the effects of memantine with a placebo on memory and thinking in participants receiving whole brain radiotherapy. Doctors hope that memantine will be effective in preventing thinking problems after whole brain radiotherapy, although there is no proof of this yet. In this study, the patient will get either memantine or the placebo. In addition, we want to find out what effects, memantine has on participants and their brain tumors. Memantine is currently used to help with thinking and memory for people with different types of dementia. A placebo is a non-active substance that looks the same as, and is given the same way as, an active drug being tested. The effects of the active drug are compared to the effects of the placebo.

N07C2 / The Use of Wisconsin Ginseng (panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

The purpose of this research study is to:
• See if taking Wisconsin Ginseng, an herbal product, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
• See the effects of taking Wisconsin Ginseng.
• See if Wisconsin Ginseng can improve stress, vitality, mood, function, and general quality of life.

RTOG 0433 / A Phase III International Randomized Trial of Single Versus Multiple Fractions For Re-Irradiation of Painful Bone Metastases

The purpose of this study is to examine the effects of re-irradiation given in a single dose compared to re-irradiation given in multiple smaller doses on people with painful bone metastases.

RTOG 0517 / Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer

The purpose of this study is to compare the effects of two different combinations of drugs to see which is better. One combination includes zoledronic acid (Zometa®), vitamin D and a calcium supplement. Zoledronic acid is a drug given through the vein to strengthen bones. The other combination includes zoledronic acid, vitamin D, and a calcium supplement plus one of two types of a radiopharmaceutical. A radiopharmaceutical is a radioactive drug given through the vein to attack cancer in the bone. In this study, the patient will get one of the combinations of drugs, not both.

N0574 / Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases

The purpose of this research study is to compare overall survival and to compare the effects of radiosurgery (SRS) to radiosurgery plus whole brain radiation therapy (WBRT) on brain metastases.

Prevention Trials

E5597 / Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer

The purpose of this study is to find out if a high selenium yeast tablet can prevent new lung cancers in people with surgically removed non-small cell lung cancer. The study will compare how the high selenium yeast affects patients with surgically removed lung cancer when compared to a placebo yeast.

Registry Trials

N08C1 / Paclitaxel-Associated Acute Pain Syndrome Natural History Study

The purpose of this research study is to gather information about the amount and type of pain, if any, you experience while receiving paclitaxel chemotherapy treatment. In addition, a blood sample will be drawn to learn how certain genes (units of heredity or traits that are passed down from generation to generation) may make you more or less likely to experience paclitaxel-associated pain.