Brief Title
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
response rate
Secondary Outcome
response duration time to response time to progression survival safety
Condition
Peritoneal Cancer
Intervention
Topotecan
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
75
Start Date
December 2002
Primary Completion Date
September 2004
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
GSK Clinical Trials, MD, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00061308
Organization ID
104864/627
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, MD, PhD, Study Director, GlaxoSmithKline
Verification Date
March 2013