Last updated: 11/03/2018 01:17:11
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Topotecan
Drug: Gemcitabine
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Peritoneal Cancer, Ovarian Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
December 2002 to September 2004
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
- At least 4 weeks since last surgery or radiation therapy.
- Women of child-bearing potential that do not practice adequate contraception.
- Pregnant or lactating.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
St. Louis, Montana, United States, 63117
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37403
Status
Study Complete
Location
GSK Investigational Site
Abington, Pennsylvania, United States, 19001-3788
Status
Study Complete
Location
GSK Investigational Site
Southfield, Michigan, United States, 48075
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7570
Status
Study Complete
Location
GSK Investigational Site
Lansing, Michigan, United States, 48912
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29601
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Status
Study Complete
Location
GSK Investigational Site
Hattiesburg, Mississippi, United States, 39401
Status
Study Complete
Location
GSK Investigational Site
Los Gatos, California, United States, 95032
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31902
Status
Study Complete
Location
GSK Investigational Site
Hinsdale, Illinois, United States, 60521
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-07-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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