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

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

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
Malignant Tumor of Peritoneum Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer	Drug: Topotecan Drug: Gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Gemcitabine Topotecan hydrochloride Gemcitabine hydrochloride Topotecan

U.S. FDA Resources

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

Intervention Details:

Other Names:

Gemcitabine
Topotecan

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 19 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00061308 History of Changes
Other Study ID Numbers:	104864/627
Study First Received:	May 23, 2003
Last Updated:	March 17, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Ovarian cancer
peritoneal cancer
cancer
Fallopian cancer

Additional relevant MeSH terms:

Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Topotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012