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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00343044
First received: June 20, 2006
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Drug: bevacizumab and topotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Resource links provided by NLM:


Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Progression Free Survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: June 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343044

Locations
United States, Washington
Puget Sound Oncology Consortium (PSOC)
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
GlaxoSmithKline
Genentech
Investigators
Principal Investigator: Kathryn McGonigle, MD Virginia Mason Medical Center
  More Information

Additional Information:
No publications provided by Benaroya Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00343044     History of Changes
Other Study ID Numbers: 3040200, AVF3648s
Study First Received: June 20, 2006
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Benaroya Research Institute:
platinum resistant ovarian cancer
recurrent ovarian cancer
platinum resistant cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Topotecan
Bevacizumab
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014