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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Centocor Ortho Biotech Services, L.L.C.
• Treatments: Bevacizumab; Carboplatin; Doxorubicin; Liposomal doxorubicin

Criteria

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.