Clinical trial NCT00343044: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: platinum resistant ovarian cancer
recurrent ovarian cancer
platinum resistant cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Genentech, Inc.
First posted: 2006-06-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression Free Survival
timeFrame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Secondary outcomes:
measure: Evaluation of Overall Survival
timeFrame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
measure: Objective Response Rate
timeFrame: Response
measure: Number or Participants With Toxicity
timeFrame: measured at each treatment cycle
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Puget Sound Oncology Consortium (PSOC)
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Kathryn McGonigle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.