Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech, Inc.
Information provided by (Responsible Party):
Beth Edelheit, Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00343044
First received: June 20, 2006
Last updated: April 29, 2015
Last verified: April 2015

June 20, 2006
April 29, 2015
June 2006
January 2010   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ] [ Designated as safety issue: No ]
Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
Progression Free Survival
Complete list of historical versions of study NCT00343044 on ClinicalTrials.gov Archive Site
  • Evaluation of Overall Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ] [ Designated as safety issue: No ]
    Overall survival was defined as the number of months after commencing study treatment to death.
  • Objective Response Rate [ Time Frame: Response ] [ Designated as safety issue: No ]
    RECIST criteria
  • Number or Participants With Toxicity [ Time Frame: measured at each treatment cycle ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Drug: Topotecan
    Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
    Other Name: Hycamtin
  • Drug: Bevacizumab
    bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
    Other Name: Avastin
Experimental: Treatment
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
Interventions:
  • Drug: Topotecan
  • Drug: Bevacizumab
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
August 2011
January 2010   (final data collection date for primary outcome measure)

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
No
Beth Edelheit, Benaroya Research Institute
Benaroya Research Institute
  • GlaxoSmithKline
  • Genentech, Inc.
Principal Investigator: Kathryn McGonigle, MD Virginia Mason Medical Center
Benaroya Research Institute
April 2015

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