Expired Study
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Orange, California 92868


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00006224


Primary Contact:

Study Chair
Russell J. Schilder, MD
Fox Chase Cancer Center


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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