Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced 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 way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy 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; Topotecan

Criteria

Inclusion Criteria:

• Histologically confirmed primary invasive carcinoma of the uterine cervix

• Stages IB2, II, IIIB, and IVA disease

• Any cell type

• No known metastasis to scalene nodes or organs outside the radiation field

• No known intraperitoneal metastases

• No evidence of extrapelvic disease based on negative CT or PET scan

• Must enroll within 8 weeks of diagnosis

• Performance status - GOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine normal

• Creatinine clearance > 50 mL/min

• Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed

• No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

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

• No septicemia or severe infection

• No other medical or psychiatric condition that would preclude study compliance

• No prior chemotherapy for any prior malignancy

• No prior cytotoxic chemotherapy for this malignancy

• No prior radiotherapy for any prior malignancy

• No prior pelvic or abdominal radiotherapy for this malignancy

• No prior therapy for this malignancy