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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00061308
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
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 : December 2002
Actual Primary Completion Date : September 2004



Intervention Details:
  • Drug: Topotecan
  • Drug: Gemcitabine
    Other Name: Topotecan


Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. response duration time to response time to progression survival safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061308


Locations
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United States, California
GSK Investigational Site
Los Gatos, California, United States, 95032
GSK Investigational Site
Santa Rosa, California, United States, 95403
United States, District of Columbia
GSK Investigational Site
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
GSK Investigational Site
Hollywood, Florida, United States, 33021
United States, Georgia
GSK Investigational Site
Columbus, Georgia, United States, 31902
United States, Illinois
GSK Investigational Site
Hinsdale, Illinois, United States, 60521
United States, Michigan
GSK Investigational Site
Lansing, Michigan, United States, 48912
GSK Investigational Site
Southfield, Michigan, United States, 48075
United States, Mississippi
GSK Investigational Site
Hattiesburg, Mississippi, United States, 39401
United States, Montana
GSK Investigational Site
St. Louis, Montana, United States, 63117
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14620
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7570
United States, Pennsylvania
GSK Investigational Site
Abington, Pennsylvania, United States, 19001-3788
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29601
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37403
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1C4
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00061308    
Other Study ID Numbers: 104864/627
First Posted: May 28, 2003    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: March 2013
Keywords provided by GlaxoSmithKline:
Ovarian cancer
peritoneal cancer
cancer
Fallopian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Gemcitabine
Topotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents