Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent, persistent, or metastatic cervical cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic disease). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.
DISEASE CHARACTERISTICS:
Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Birmingham, Alabama 35294-3300, United States
Los Angeles, California 90033-0804, United States
Chicago, Illinois 60611-W227, United States
Hines, Illinois 60141, United States
Lexington, Kentucky 40536-0084, United States
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Jamaica Plain, Massachusetts 02130, United States
Rochester, New York 14642, United States
San Antonio, Texas 78229-3900, United States