Current clinical trials at Bay Area Hospital

Breast

S1207 Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. Further information available at http://clinicaltrials.gov/ct2/show/NCT01674140
 
ABI-007-MBC-001 Phase 2/3 multi-center , open-label, randomized study of weekly nab-paclitaxel in combination with Gemcitabine or carboplatin, compared to gemcitabine/carboplatin, as first line treatment in subjects with ER,PR< and HER2 negative metastatic breast cancer. Further information available at http://clinicaltrials.gov/show/NCT01881230
 
CDX-011-04: Site PI: Bret Cook, MD. A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study). This study is looking at the use of a new drug for women with advanced triple negative breast cancer that contains GPNMB, a molecule that is sometimes expressed on cancer cells. Further information available at http://clinicaltrials.gov/ct2/show/NCT01997333
 
A5481023: Site PI: Bret Cook MD. Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Faslodex®) With or Without PD-0332991 (Palbociclib) ± Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy. This study is comparing adding Palbociclib to Faslodex in women with hormone receptor positive and HER2 negative metastatic breast cancer. Further information available http://www.clinicaltrials.gov/ct2/show/NCT01942135
 
Kidney
 
S0931: Site PI: Bret Cook, MD. “EVEREST”: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study. This study is trying to see if using everolimus after surgical removal of kidney cancer will increase the time without cancer returning. Further information available at http://clinicaltrials.gov/ct2/show/NCT01120249
 
Lung Cancer
  
MO22097: An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy. This study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin maintenance treatment prior to PD. Patients will be randomly assigned to one of two treatment arms to receive either Avastin plus standard of care treatment or standard of care treatment alone. Further information available at http://clinicaltrials.gov/show/NCT01351415.
 
Melanoma
  
E1609: Site PI: Bret Cook, MD. A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma. This clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery. Further information available http://clinicaltrials.gov/ct2/show/NCT01274338
  
Myelodysplastic Syndrome
 
E2905: Site PI: Bret Cook, MD. Lenalidomide With or Without Epoetin Alfa in Treating Patients with Myelodysplastic Syndrome and Anemia. This trial is studying lenalidomide (Revlamid) to see how well it works with or without epoetin alfa (Procrit) in treating patients with myelodysplastic syndrome and anemia. Further information available at http://clinicaltrials.gov/ct2/show/NCT00843882.
 
Prostate Cancer
 
CALGB 70807: Site PI: Leo Kusuda, MD. The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance. Further information available at http://clinicaltrials.gov/ct2/show/NCT01238172.
 
CALGB 90203: Site PI: Bret Cook, MD. Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients with High-Risk Localized Prostate Cancer. This trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer. Further information available at http://clinicaltrials.gov/ct2/show/NCT00430183.
 

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