Status:
COMPLETED
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 platin...
Detailed Description
DOXIL pegylated liposomal doxorubicin (PLD) is approved for use in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Data suggest that combinatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00698451
Start Date
August 1 2008
End Date
October 1 2010
Last Update
September 6 2013
Active Locations (1)
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1
Horsham, Pennsylvania, United States, 19044