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A Phase II Study of Carboplatin and Gemcitabine with or without Bevacizumab in Patients with Platinum-Sensitive Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
[Protocol 07-078]
- Full Title :
- A PHASE III, MULTICENTER, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED TRIAL OF CARBOPLATIN AND GEMCITABINE PLUS BEVACIZUMAB IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARY, PRIMARY PERITONEAL, OR FALLOPIAN TUBE CARCINOMA
- Purpose :
Carboplatin and gemcitabine comprise a standard treatment for patients with ovarian, primary peritoneal, and fallopian tube cancers that have recurred despite prior platinum-based chemotherapy. The main goal of this study is to assess the safety of adding bevacizumab (Avastin®) to this standard treatment.
Bevacizumab is a drug that has been approved for treating advanced colorectal cancer and non-small cell lung cancer, and it is showing promise for the treatment of other forms of advanced cancer. It works by attaching to a protein in the blood stream called vascular endothelial growth factor (VEGF), which helps tumors grow new blood vessels to feed themselves. Bevacizumab is thought to help block this new growth of blood vessels (angiogenesis) and starve the tumors of the nutrients they need.
In this study, patients will be randomly assigned to receive carboplatin and gemcitabine with bevacizumab or a placebo.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that has recurred more than 6 months after completing platinum-based chemotherapy. Patients may not have received prior chemotherapy for recurrent disease.
- At least 4 weeks must have passed since prior major surgery or radiation therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients may not have had prior therapy that included bevacizumab or similar drugs that work by targeting VEGF.
- Patients must be age 18 or older.
For more information and to inquire about eligibility, please contact Dr. Carol Aghajanian at 212-639-2252.
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