Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine

Criteria

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