Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

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

Summary

This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed primary invasive carcinoma of the uterine cervix

• Previously untreated disease

• Any cell type

• Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA

• Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy

• No known metastases to scalene nodes or other organs outside the radiotherapy field

• Study enrollment within 8 weeks of diagnosis

• Performance status - GOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

• Creatinine less than 2.0 mg/dL

• No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields

• No ureteral obstruction allowed unless treated with stent or nephrostomy tube

• Not pregnant

• Fertile patients must use effective contraception

• No septicemia or severe infection

• No circumstance that would preclude study completion or follow-up

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No prior cytotoxic chemotherapy

• No prior pelvic or abdominal radiotherapy

• No prior therapy for this malignancy