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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061308
• Other study ID #: 104864/627
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2003
• Last updated: June 8, 2017
• Start date: December 2002

Study information

• Verified date: March 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Ovarian
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Topotecan

• Gemcitabine

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
United States	GSK Investigational Site	Abington	Pennsylvania
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Hattiesburg	Mississippi
United States	GSK Investigational Site	Hinsdale	Illinois
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Los Gatos	California
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	Southfield	Michigan
United States	GSK Investigational Site	St. Louis	Montana
United States	GSK Investigational Site	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate
Secondary	response duration time to response time to progression survival safety

External Links

•   A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.