Trial Information

Summary: Research Study of Carboplatin and DOXIL plus Bevacizumab in Patients with Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

The purpose of this research study is to determine how well the combination of DOXILŽ plus carboplatin and bevacizumab (AVASTINŽ) works in treating your type of cancer and to determine the types and severity of side effects caused by treatment with these drugs.

DOXIL, carboplatin and bevacizumab are drugs approved by the United States Food and Drug Administration (FDA) for various cancers. Patients have been treated with these drugs alone or in various combinations with other drugs as part of research studies. Researchers would like to see if the combination of DOXIL, carboplatin and bevacizumab would work even better.

All research study patients will receive DOXIL, carboplatin and bevacizumab by intravenous (IV) infusion for a maximum of ten (10) 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Please click on the following link to be re-directed to a website that will allow you to pre-screen for the study. Through this website you may request more information and request to be contacted by a study physician for possible participation in this research study. http://host.veritasmedicine.com/index.cfm?vip=4991-872-252200

You may also go to www.clinicaltrials.gov for more information about the study. The study specific link is http://www.clinicaltrials.gov/ct2/show/NCT00698451?term=doxilovc2007&rank=1

The key inclusion and exclusion criteria to participate in this research study are described below. There are other criteria in addition to these that are not listed and will be reviewed with you by your study doctor.

Inclusion Criteria:

• Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
• Relapse-free interval of >6 months afer completion of first line platinum-based chemotherapy
• Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension)
• Adequate bone marrow function, renal, and liver function. Normal cardiac function
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

• No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen)
• No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
• No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation
• No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin
• No patients with clinically significant cardiovascular disease
• No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted agent use

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Trial listings updated: September 30, 2008 at 2:08:44 PM