Clinical trial NCT00061308: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Cancer
Ovarian Cancer
Neoplasms, Ovarian
Fallopian Tube Cancer
Keywords: Ovarian cancer
peritoneal cancer
cancer
Fallopian cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-05-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: response duration time to response time to progression survival safety
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: GSK Investigational Site
state: California
city: Santa Rosa
country: United States
facility: GSK Investigational Site
state: California
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Hinsdale
country: United States
facility: GSK Investigational Site
state: Illinois
city: Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Southfield
country: United States
facility: GSK Investigational Site
state: Michigan
city: Hattiesburg
country: United States
facility: GSK Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Montana
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Abington
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD, PhD
role: STUDY_DIRECTOR
References: