Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

April 29, 2015 updated by: Beth Edelheit, Benaroya Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • Puget Sound Oncology Consortium (PSOC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
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.
Drug: Topotecan
Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
Other Names:
  • Hycamtin
Drug: Bevacizumab
bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Overall Survival
Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Overall survival was defined as the number of months after commencing study treatment to death.
PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Objective Response Rate
Time Frame: Response
RECIST criteria
Response
Number or Participants With Toxicity
Time Frame: measured at each treatment cycle
measured at each treatment cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Collaborators

GlaxoSmithKline
Genentech, Inc.

Investigators

  • Principal Investigator: Kathryn McGonigle, MD, Virginia Mason Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

June 20, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (ESTIMATE)

June 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3040200
  • AVF3648s (OTHER: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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