Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
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.
Detailed description
OBJECTIVES: * Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. * Determine the toxicity of this regimen in these patients. 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.
Interventions
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: * Adenocarcinoma * Adenosquamous carcinoma * Undifferentiated carcinoma * Must have documented disease progression * Histologic confirmation of original primary tumor required * Bidimensionally measurable disease * Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT and alkaline phosphatase no greater than 3 times normal Renal: * Creatinine no greater than 1.5 mg/dL Other: * No significant infection * Not pregnant * Fertile patients must use effective contraception * No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) Chemotherapy: * No prior gemcitabine * At least 3 weeks since other prior chemotherapy for cervical cancer and recovered * No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy) Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy for cervical cancer and recovered Surgery: * At least 3 weeks since prior surgery for cervical cancer and recovered Other: * No prior cancer treatment that would preclude study
Countries
Canada, United States
Outcome results
None listed