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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00061308

Collaborator

(none)

Enrollment

Locations

3.9

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer	Drug: Topotecan Drug: Gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

response rate []

Secondary Outcome Measures

response duration time to response time to progression survival safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Los Gatos	California	United States	95032
2	GSK Investigational Site	Santa Rosa	California	United States	95403
3	GSK Investigational Site	Washington, D.C.	District of Columbia	United States	20010
4	GSK Investigational Site	Hollywood	Florida	United States	33021
5	GSK Investigational Site	Columbus	Georgia	United States	31902
6	GSK Investigational Site	Hinsdale	Illinois	United States	60521
7	GSK Investigational Site	Lansing	Michigan	United States	48912
8	GSK Investigational Site	Southfield	Michigan	United States	48075
9	GSK Investigational Site	Hattiesburg	Mississippi	United States	39401
10	GSK Investigational Site	St. Louis	Montana	United States	63117
11	GSK Investigational Site	Rochester	New York	United States	14620
12	GSK Investigational Site	Chapel Hill	North Carolina	United States	27599-7570
13	GSK Investigational Site	Abington	Pennsylvania	United States	19001-3788
14	GSK Investigational Site	Greenville	South Carolina	United States	29601
15	GSK Investigational Site	Chattanooga	Tennessee	United States	37403
16	GSK Investigational Site	Calgary	Alberta	Canada	T2N 4N2
17	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 4E6
18	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 1C4
19	GSK Investigational Site	Toronto	Ontario	Canada	M4N 3M5