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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. Identifier: NCT00061308
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):

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

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 identifier (NCT number): NCT00061308

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT00061308     History of Changes
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
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
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents