Brief Title
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official Title
A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
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 sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal
cancer.
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 participant is not experiencing any unacceptable side effects, participation can
continue up to 2 years. The study is being done to find the effectiveness, safety and
tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new
blood vessels in the body. It is part of this study to see if stopping the growth of new
blood vessels in the body will help stop the growth and the spread of cancer. The other two
chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the
treatment of ovarian cancer.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Secondary Outcome
Overall Survival for Patients Treated With the Regimen.
Condition
Ovarian Cancer
Intervention
Bevacizumab
Study Arms / Comparison Groups
Gemcitabine/carboplatin/bevacizumab
Description: A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
45
Start Date
November 2005
Completion Date
December 2013
Primary Completion Date
September 2013
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Larry J. Copeland, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00267696
Organization ID
OSU-05070
Responsible Party
Principal Investigator
Study Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Genentech, Inc.
Study Sponsor
Larry J. Copeland, MD, Principal Investigator, Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
Verification Date
April 2015