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Second-Line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
This study has been completed.
First Received: May 23, 2003   Last Updated: May 15, 2009   History of Changes
Sponsored by: 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
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: Topotecan
Drug: Gemcitabine
Phase II

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

Resource links provided by NLM:


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 19 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 104864/627
Study First Received: May 23, 2003
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00061308     History of Changes
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:
Antimetabolites
Fallopian Tube Cancer
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Peritoneal Diseases
Ovarian Cancer
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Antiviral Agents
Immunosuppressive Agents
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Topotecan

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Abdominal Neoplasms
Immunosuppressive Agents
Antiviral Agents
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on July 02, 2009