Clinical Trial: Safety and Efficacy Study of Gemcitabine Plus Bevacizumab in Patients With Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Trial of Gemcitabine Plus Bevacizumab in Patients With Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Brief Summary: The purpose of the study is to determine whether the administration of bevacizumab and gemcitabine given by IV infusion can prolong survival, delay tumor growth, and/or shrink tumors in patients with ovarian cancer, primary peritoneal, or fallopian tube cancer.

Detailed Summary:
Sponsor: Emory University

Current Primary Outcome: Progression-free survival [ Time Frame: 2 years ]

The primary outcome measure is progression-free survival. Disease status and response rates will be determined by investigator assessment using RECIST or CA-125 changes (subjects with nonmeasurable disease only)


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety and tolerability of bevacizumab in combination with gemcitabine will be assessed. [ Time Frame: 2 years ]

The safety and tolerability of bevacizumab in combination with gemcitabine will be assessed using the following measures:

- Incidence, nature, severity, and relatedness of adverse events graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE, Version 3.0)



Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: May 21, 2010
Date Started: January 2011
Date Completion:
Last Updated: December 19, 2013
Last Verified: December 2013