Brief Title
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Official Title
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression Free Survival
Secondary Outcome
Evaluation of Overall Survival
Condition
Ovarian Cancer
Intervention
Topotecan
Study Arms / Comparison Groups
Treatment
Description: 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.
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
40
Start Date
June 2006
Completion Date
August 2011
Primary Completion Date
January 2010
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kathryn McGonigle, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00343044
Organization ID
3040200
Secondary IDs
AVF3648s
Responsible Party
Principal Investigator
Study Sponsor
Benaroya Research Institute
Collaborators
GlaxoSmithKline
Study Sponsor
Kathryn McGonigle, MD, Principal Investigator, Virginia Mason Medical Center
Verification Date
April 2015