Second-Line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer - Full Text View

Purpose

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	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer	Drug: Topotecan Drug: Gemcitabine	Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

Drug Information available for:

Gemcitabine hydrochloride Gemcitabine Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Safety/Efficacy Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

response rate

Secondary Outcome Measures:

response duration time to response time to progression survival safety

Estimated Enrollment:	75
Study Start Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061308

Show 20 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD, PhD	GlaxoSmithKline

More Information

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Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104864/627
First Received:	May 23, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00061308
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Ovarian cancer

Fallopian cancer

peritoneal cancer

cancer

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Fallopian Tube Neoplasms

Recurrence

Fallopian Tube Diseases

Genital Diseases, Female

Endocrinopathy

Fallopian tube cancer

Topotecan

Gemcitabine

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Adnexal Diseases

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00061308