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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006224 |
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.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Evaluation of Gemcitabine in Persistant or Recurrent Non-Squamous Cell Carcinoma of the Cervix |
Study Start Date: | September 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable
Eligible subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068144, GOG-0128F |
Study First Received: | September 11, 2000 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00006224 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma |
Antimetabolites Immunologic Factors Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma |
Uterine Cervical Neoplasms Genital Diseases, Female Uterine Cervical Diseases Radiation-Sensitizing Agents Uterine Neoplasms Adenocarcinoma Gemcitabine Carcinoma, Adenosquamous |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Urogenital Neoplasms Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Uterine Cervical Neoplasms Genital Diseases, Female Neoplasms Uterine Cervical Diseases Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Uterine Neoplasms Gemcitabine |