Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine; Cisplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven, locally advanced carcinoma of the uterine cervix

• TNM classification stage IIIB or IVA

• Disease metastatic to para-aortic or high common iliac lymph nodes

• Prior complete surgical resection of involved lymph nodes or gross residual tumor involvement of a lymph node allowed

• The following cellular types are eligible:

• Squamous cell carcinoma

• Adenocarcinoma

• Adenosquamous carcinoma

• The following cellular types are ineligible:

• Small cell carcinoma

• Carcinoid tumor

• Glassy cell carcinoma

• Clear cell carcinoma

• Cystadenocarcinoma

• No metastatic disease outside of the pelvis (except to the para-aortic nodes)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• At least 6 months

Hematopoietic

• White blood cell count (WBC) at least 3,000/mm^3

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• Alanine amino transferase (ALT) no greater than 2 times normal

Renal

• Creatinine no greater than 1.5 mg/dL (urinary diversion allowed)

• Corrected calcium normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No concurrent significant medical condition that would preclude study participation

• No insulin-dependent diabetes

• No other malignancy within the past 3 years except cutaneous basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic irradiation except transvaginal radiotherapy to control bleeding

Surgery

• See Disease Characteristics

• No prior tumor-directed surgery except lymph node biopsy/staging