ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Second-Line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

This study has been completed.

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

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  Show 20 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD, PhD     GlaxoSmithKline    
  More Information


A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.  This link exits the ClinicalTrials.gov site
 

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




Links to all studies - primarily for crawlers