Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
NCT ID: NCT00061308
Last Updated: 2017-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2002-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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Topotecan
Gemcitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials, MD, PhD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Los Gatos, California, United States
GSK Investigational Site
Santa Rosa, California, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Hollywood, Florida, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Hinsdale, Illinois, United States
GSK Investigational Site
Lansing, Michigan, United States
GSK Investigational Site
Southfield, Michigan, United States
GSK Investigational Site
Hattiesburg, Mississippi, United States
GSK Investigational Site
Saint Louis, Montana, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Abington, Pennsylvania, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Chattanooga, Tennessee, United States
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
Countries
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Related Links
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A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.
Other Identifiers
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104864/627
Identifier Type: -
Identifier Source: org_study_id
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