Last updated: 11/03/2018 01:17:11

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

GSK study ID
104864/627
See study documents
Clinicaltrials.gov ID
NCT00061308
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Montana, United States, 63117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37403
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Abington, Pennsylvania, United States, 19001-3788
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Southfield, Michigan, United States, 48075
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599-7570
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lansing, Michigan, United States, 48912
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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