Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
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
1 other identifier
interventional
75
2 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 23, 2003
CompletedFirst Posted
Study publicly available on registry
May 28, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedJune 9, 2017
March 1, 2013
1.8 years
May 23, 2003
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
Secondary Outcomes (1)
response duration time to response time to progression survival safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (19)
GSK Investigational Site
Los Gatos, California, 95032, United States
GSK Investigational Site
Santa Rosa, California, 95403, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Columbus, Georgia, 31902, United States
GSK Investigational Site
Hinsdale, Illinois, 60521, United States
GSK Investigational Site
Lansing, Michigan, 48912, United States
GSK Investigational Site
Southfield, Michigan, 48075, United States
GSK Investigational Site
Hattiesburg, Mississippi, 39401, United States
GSK Investigational Site
Saint Louis, Montana, 63117, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7570, United States
GSK Investigational Site
Abington, Pennsylvania, 19001-3788, United States
GSK Investigational Site
Greenville, South Carolina, 29601, United States
GSK Investigational Site
Chattanooga, Tennessee, 37403, United States
GSK Investigational Site
Calgary, Alberta, T2N 4N2, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E6, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 1C4, Canada
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD, PhD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2003
First Posted
May 28, 2003
Study Start
December 1, 2002
Primary Completion
September 1, 2004
Last Updated
June 9, 2017
Record last verified: 2013-03