Status:
COMPLETED
Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
Lead Sponsor:
Gynecologic Oncology Associates
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). T...
Detailed Description
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy. This involves an optimal p...
Eligibility Criteria
Inclusion
- Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
- Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
- If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
- Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC \> 3,000 cells/cu ml., platelets \> 100,000/cu.ml., calculated creatinine clearance \> 50 ccs/min., bilirubin \< 1.5 mg/dl, and SGOT \< three times normal.
- Karnofsky performance status \> 50%.
- Subjects who have signed an institutional review board (IRB) approved informed consent form.
Exclusion
- Subjects with epithelial ovarian cancer of low malignancy potential.
- Subjects with septicemia, severe infection, or acute hepatitis.
- Subjects with severe gastrointestinal bleeding.
- Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00127920
Start Date
August 1 2004
End Date
October 1 2012
Last Update
March 10 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
2
Florida Hospital College of Health Sciences
Orlando, Florida, United States, 32803