Phase 2
N=40
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00343044 ↗Enrolled (actual)
40
Serious AEs
22.5%
Results posted
May 2015
Primary outcome: Primary: Progression Free Survival — 7.8; 2.8; 10.9 months — p=.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Topotecan (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Benaroya Research Institute
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
7.8; 2.8; 10.9 | .08 |
| SECONDARY Evaluation of Overall Survival |
16.6; 12.8; 22.9 | .02 sig |
| SECONDARY Objective Response Rate |
10 | — |
| SECONDARY Number or Participants With Toxicity |
40 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00343044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.