Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech, Inc.
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00343044
First received: June 20, 2006
Last updated: May 25, 2010
Last verified: May 2010

June 20, 2006
May 25, 2010
June 2006
Not Provided
Progression Free Survival
Same as current
Complete list of historical versions of study NCT00343044 on ClinicalTrials.gov Archive Site
  • Evaluation of overall survival, complete response, partial response, stable disease, and
  • measure effect of this treatment on CA-125 levels
  • Evaluation of toxicities: type and severity
Same as current
Not Provided
Not Provided
 
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
Drug: bevacizumab and topotecan
Not Provided
McGonigle KF, Muntz HG, Vuky J, Paley PJ, Veljovich DS, Greer BE, Goff BA, Gray HJ, Malpass TW. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer: results of a phase 2 study. Cancer. 2011 Aug 15;117(16):3731-40. doi: 10.1002/cncr.25967. Epub 2011 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
Not Provided

Inclusion Criteria:

  • must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen
  • must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line)
  • must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart
  • performance status greater than or equal to 70%

Exclusion Criteria:

  • prior treatment with anti-angiogenesis agent
  • treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
  • evidence of other malignancy within 3 years of study enrollment
  • history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation
  • history of intra-abdominal abscess with 6 months prior to day 0
  • pregnant or lactating patients
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00343044
3040200, AVF3648s
Not Provided
Not Provided
Benaroya Research Institute
  • GlaxoSmithKline
  • Genentech, Inc.
Principal Investigator: Kathryn McGonigle, MD Virginia Mason Medical Center
Benaroya Research Institute
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP