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Tracking Information | |||||
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First Received Date † | September 11, 2000 | ||||
Last Updated Date | October 12, 2008 | ||||
Start Date † | September 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00006224 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix | ||||
Official Title † | Evaluation of Gemcitabine in Persistant or Recurrent Non-Squamous Cell Carcinoma of the Cervix | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Cervical Cancer | ||||
Intervention † | Drug: gemcitabine hydrochloride | ||||
Study Arms / Comparison Groups | |||||
Publications * | Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00006224 | ||||
Responsible Party | |||||
Secondary IDs †† | GOG-0128F | ||||
Study Sponsor † | Gynecologic Oncology Group | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | June 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |