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Keep this study
Lead
Gynecologic Oncology Group
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days 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: A total of 28-69 patients will be accrued for this study.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
Must have had 1 prior chemotherapy regimen for cervical cancer
* No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
* No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
Bidimensionally measurable disease
Ineligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
GOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Platelet count at least lower limit of normal
Absolute neutrophil 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 2.0 mg/dL
Other:
Not pregnant
Fertile patients must use effective contraception
No significant infection
No other malignancies within past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 3 weeks since prior biologic therapy for cervical cancer
Chemotherapy:
See Disease Characteristics
At least 3 weeks since prior chemotherapy for cervical cancer and recovered
No prior gemcitabine
Endocrine therapy:
At least 3 weeks since prior endocrine therapy for cervical cancer
Radiotherapy:
At least 3 weeks since prior radiotherapy for cervical cancer and recovered
No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
No concurrent amifostine or other protective reagents
No prior anticancer therapy that contraindicates study
