HIC 10-9 CALGB 40503 - Endocrine Therapy With or Without anti-VEGF Therapy: A Randomized Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865-IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer

• Women with advanced breast cancer that is positive for either the estrogen receptor and/or progesterone receptor.
  This means that the cancer is potentially sensitive to anti-estrogen therapy, also called endocrine or hormone therapy may be eligible for this study. The study will compare two arms: Group 1 – participants will swallow one endocrine therapy pill daily and receive bevacizumab through their vein every 3 weeks. Group 2 – participants will swallow one endocrine therapy pill daily only.

HIC 10-11 CTSU NCIC CTG MA32 - A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

• Women with early stage breast cancer who have had surgery to remove it may be eligible for this study. The study will compare Metformin, a drug used to treat diabetes, to see if it may decrease or affect the ability of breast cancer cells to grow. The study will compare two arms: Group 1 – participants will swallow one metformin caplet daily for 4 weeks, then increase to one metformin caplet twice a day. Group 2 – participants will be taking a placebo.

CALGB 40603: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose Dense AC in Hormone Receptor Poor / HER 2 Negative Resectable Breast Cancer

• Women who have triple negative breast cancer may be eligible for this trial. The study will evaluate whether adding other drugs to standard neoadjuvant chemotherapy can help shrink triple-negative breast cancer faster and lower the risk of the cancer coming back in other parts of the body.

CALGB 40601: Randomized Phase III Trial of Paclitaxel Combined with Transtuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer)

• Patients who have operable stage II-III invasive breast cancer that is HER2 positive may be eligible for this study. Patients will be randomized to one of three groups to compare tumor shrinkage prior to surgery: paclitaxel and trastuzumab given by vein and lapatinib taken by mouth; or paclitaxel and trastuzmab by vein; or paclitaxel and lapatinib taken by mouth. All three groups will have surgery to remove any remaining breast cancer.

CALGB 40502: 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

• Patients who have locally recurrent or metastatic breast cancer and have not had chemotherapy treatment for the disease may be eligible for this study. Patients will be randomized to one of three groups using different chemotherapy agents in combination with bevacizumab.

CTSU N063D: ALTTO-adjuvant Lapatinib and/or Transtuzumab Treatment Optimization Study: Randomized, 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

• Patients who have HER2+ early breast cancer may be eligible for this study. All patients will receive paclitaxel and then would be enrolled into one of four groups to receive: standard treatment – trastuzumab; lapatinib; trastuzumab and then lapatinib; or trastuzmab and lapatinib together for up to 1 year. Paclitaxel and trastuzmab are given in the vein and lapatinib is a pill.

• Patient with newly diagnosed glioblastoma may be eligible for this study. The study will evaluate the addition of bevacizumab given through a vein in improving overall outcomes of patients with this disease. Patients will be randomized to receive bevacizumab or placebo to the standard care.

HIC 10-1 CTSU WFU 91105: Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated Brain Tumor Patients

• Patients who have received radiation therapy for a brain tumor may be eligible for this study. The purpose of this study is to see if the study drug, donepezil (Aricept), will improve memory loss, confusion and slow thinking that have occurred after getting radiation treatments for a brain tumor. The study will also look at whether donepezil improves mood and quality of life.

RTOG 0614: Randomized, Phase III, Double-blind, Placebo-controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-brain Radiotherapy

• Patients who are scheduled to receive whole-brain radiation may be eligible for this study. Patients will be randomized to receive either memantine(a pill) or placebo for a total of 24 weeks to see if memantine is effective in preventing memory problems for patients receiving whole-brain radiation.

HIC 10-10 CALGB 80702 A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

• Patients who have colon cancer, which has been surgically removed, but has spread to the lymph nodes may be eligible for this study. The study will compare 4 different “arms” of treatment. FOLFOX consists of the combination of these chemotherapy agents: 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin. For Groups 1 and 2 - Patients will receive an intravenous (through the vein in your arm) treatment of FOLFOX every other week for a total of 12 treatments or 24 weeks. Group 1 will also receive a placebo pill. Group 2 will also receive a celecoxib pill. Groups 3 and 4 – Patients will receive an intravenous treatment of FOLFOX every other week for a total of 6 treatments or 12 weeks. Group 3 will also receive a placebo and Group 4 will receive celoxib.

CALGB/SWOG 80405: Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

• Patients with cancer of the colon or rectum which has spread and has not yet been treated will be randomly assigned to receive one of two standardized chemotherapy treatments with an additional approved drug
  OR one of two standardized chemotherapy treatments with an experimental drug
  OR one of two standardized chemotherapy treatments with both of these two additional drugs.

RTOC 0436: Phase III randomized trial of radiation/paclitaxel/cisplatin with or without cetuximab for esophageal cancer who are treated without surgery.

This study is evaluating if adding cetuximab to chemotherapy and radiation will improve survival in patients where surgery is not an option.

No studies available.

HIC 10-4 CALGB 30801: (A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced NSCLC)

• Patients with Advanced Non-Small Cell Lung cancer whose tumor’s have high levels of COX-2 may be eligible for this study. The purpose of the study is to see if adding celecoxib versus placebo to standard chemotherapy has any benefit.

CALGB 30607: 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 NSCLC)

• Patients with advanced stage IIIB/IV non-small cell lung cancer may be eligible for this study. Patients will be randomized to receive either Sunitinib or placebo after standard chemotherapy to see if Sunitinib helps their tumor shrink or stops growing.

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

• Patients with stage IIIA/IIIB non-small cell lung cancer who are not eligible for surgical removal (inoperable) may be eligible for this study. Patients will be randomized into one of four groups. The study will compare high dose radiation therapy and standard dose radiation as well as comparing the addition of cetuximab.

CALGB 30504: Phase IB/II Study of the Combination Cisplatin, Etoposide and Sunitinib for Untreated Extensive Stage Small Cell Lung Cancer

• Cisplatin and etoposide are currently approved for use in patients with extensive small cell lung cancer. This study adds the medication, sunitinib. Sunitinib is an oral medication that inhibits vascular endothelial growth factor. Vascular endothelial growth factor levels are elevated in many of these malignancies. In this study, a small number of patients will participate first to determine the best dose of sunitinib combined with cisplatin and etoposide. Then a larger group of patients will receive that dose and be followed for a period of time.

S0424: Molecular Epidemiology Case-series Study of Non-small Cell Lung Cancer Non-smoking Women and Men

• Men and women who are newly diagnosed with non-small cell lung cancer are eligible for this study. The researchers will assess tissue samples for specific tobacco smoke carcinogens in both smokers and non-smokers.

CALGB 10404: Randomized Phase II Study of Three Fludarabine/antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

• Patients who have been diagnosed with chronic lymphocytic leukemia (CLL) and have not had prior treatment may be eligible for this study. Patients would be randomized into one of three groups.

CALGB 9665: CALGB Leukemia Tissue Bank (A Companion Study for CALGB 10404)

• This is a companion tissue bank for patients enrolled in the CLL trial. It would allow researchers to use samples for additional studies to help evaluate better treatments.

NSABP P5: Statin polyp prevention trial is patients with resected colon cancer

• A colon cancer trial using Crestor or placebo for patients who have had a colon cancer removed by surgery. The study is being done to determine if Crestor can reduce the risk of future polyps or recurrent cancer. This is for patients who have a stage 1 or 2 colon cancer. Previously chemotherapy is allowed, but not required. Must be enrolled within 1 year from the time of diagnosis.

CALGB 70806: Vitamin D and Breast Cancer Markers

• A breast cancer prevention trial using Vitamin D or placebo for women who have been found to have dense breasts on mammogram. The study is being done to determine if vitamin D changes the density of breast tissue to allow for better evaluation of mammogram imaging. Participants must be premenopausal. Can not take more than 400ius of Vitamin D per day or willing to stop if currently taking it. Can not be on any kind of hormonal therapy. Can not have a history or breast or ovarian cancer.

RTOG 0831: A randomized, double-blinded, placebo-controlled phase III trial to evaluate the effectiveness of a phosphodiesterase 5 inhibitor, Tadalafil, in prevention of erectile dysfunction in patients treated with radiotherapy for prostate cancer

• This study is being done to evaluate the effectiveness of using Cialis or placebo to prevent erectile dysfunction in patients treated with radiation therapy. This is for men who have cancer that involves no more than 1/2 of one lobe and plan to have radiation therapy treatment. Enrollment must occur no later than 1 week after starting radiation therapy.

CALGB 90202: Randomized, Double-blind, Placebo-controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

• Patients who have metastatic to the bone prostate cancer may be eligible for this study. This study will compare the effects of early treatment with zoledronic acid (zometa) compared to standard treatment with zoledronic acid (zometa). Zoledronic acid is an intravenous infusion.

CALGB 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

• Men who have prostate cancer and are at risk of the cancer returning after surgery to remove their prostate are eligible for this study. The study will compare the effects of hormone therapy and chemotherapy before surgery compared to just surgery alone.

RTOG 0631: Phase II/III Study of Image Guided Radiosurgery / SBRT for Localized Spine Metastasis

• Multiple radiation treatments are frequently used to treat pain caused by cancer that has spread to the spine. Image guided radiosurgery/ stereotactic body radiation (SBRT) is a treatment that uses highly focused x-rays to deliver a single high dose on a specific area of the body. This study will evaluate the effect of SBRT on the cancer that has spread to the patient’s spine and also has a second phase to evaluate the effects of SBRT to Standard radiation therapy to find out which treatment provides the most rapid pain relief with the least side effects.

HIC 10-12 CTSU NCCTG N08CB - A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium / Magnesium in Two Different Versions to Prevent Oxaliplatin Induced Sensory Neurotoxicity

• Patients who will be starting chemotherapy treatment with oxaliplatin for their cancer may be eligible to participate in this trial as well. Participants will be randomized into one of three groups. Group 1 – Calcium Gluconate and magnesium sulfate will be given through a vein immediately before the chemotherapy treatment and immediately after the treatment. Group 2 – Placebo will be given through a vein immediately before the chemotherapy treatment and immediately after the treatment. Group 3 - Calcium Gluconate and magnesium sulfate will be given through a vein immediately before the chemotherapy treatment and a placebo will be given immediately after the treatment.

CALGB 70604: Randomized Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer)

• Patients with breast cancer, prostate cancer, or multiple myeloma may be eligible for this study. Patient will be randomized to receive standard dosing interval with Zoledronic acid through their vein or longer dosing interval of Zoledronic acid to compare efficacy and safety.

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