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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Principal Investigator

Kathryn McGonigle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Mason Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

3040200

NCT ID:

NCT00343044

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • platinum resistant ovarian cancer
  • recurrent ovarian cancer
  • platinum resistant cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
Virginia Mason Medical Center Seattle, Washington  98111
Puget Sound Oncology Consortium (PSOC) Seattle, Washington