Status:
COMPLETED
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Eli Lilly and Company
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sen...
Detailed Description
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participan...
Eligibility Criteria
Inclusion
- Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
- Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
- History of at least one therapy of platinum based chemotherapy.
Exclusion
- Participation in another experimental drug study
- Heart disease or high blood pressure
- History of a stroke within the past 6 months
- Vascular disease, or bleeding problems
- Brain cancer
- Major Surgical Procedure within 28 days prior to start date
- Minor surgical procedures within 7 days prior to start date
- Pregnant or lactating
- Abdominal or bowel problems like bleeding
- History of abdominal fistula, GI perforation or Intra-abdominal abscess
- Serious, non-healing wound, ulcer or bone fracture
- Acute hepatitis
- Active infections requiring antibiotics
- Inability to comply with study or follow up procedures
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00267696
Start Date
November 1 2005
End Date
December 1 2013
Last Update
April 30 2015
Active Locations (1)
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1
The Ohio State University & James Cancer Hospital
Columbus, Ohio, United States, 43210