Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

June 8, 2017 updated by: GlaxoSmithKline

An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer

This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.

Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
  • United States
    • California
      • Los Gatos, California, United States, 95032
        • GSK Investigational Site
      • Santa Rosa, California, United States, 95403
        • GSK Investigational Site
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • GSK Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31902
        • GSK Investigational Site
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • GSK Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48912
        • GSK Investigational Site
      • Southfield, Michigan, United States, 48075
        • GSK Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • GSK Investigational Site
    • Montana
      • St. Louis, Montana, United States, 63117
        • GSK Investigational Site
    • New York
      • Rochester, New York, United States, 14620
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7570
        • GSK Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001-3788
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • GSK Investigational Site

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:

  • Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
  • At least 4 weeks since last surgery or radiation therapy.
  • Must have had a treatment-free interval of greater than 6 months following response to platinum.
  • ECOG performance status of 0,1, or 2.

Exclusion Criteria:

  • Women of child-bearing potential that do not practice adequate contraception.
  • Pregnant or lactating.
  • Received more than one primary chemotherapy regimen.
  • Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.
  • Active uncontrolled infection requiring antibiotics.
  • Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.
  • Received radiation to more than 10% of bone.
  • Prior treatment with topotecan or gemcitabine.
  • Hypersensitivity to camptothecin or nucleoside analogues.
  • Use of an investigational agent within 30 days.

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: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
response rate

Secondary Outcome Measures

Outcome Measure
response duration time to response time to progression survival safety

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

December 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

May 23, 2003

First Submitted That Met QC Criteria

May 27, 2003

First Posted (Estimate)

May 28, 2003

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864/627

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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