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Therapeutic Areas: Oncology | Obstetrics/Gynecology | Endocrinology
Disease Category: Ovarian Cancer

Trial Information

A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Patient 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.

Patient 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.

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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