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.

Condition	Treatment or Intervention	Phase
radiation toxicity stage III cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma	Drug: amifostine  Drug: cisplatin  Procedure: brachytherapy  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radioprotection  Procedure: supportive care/therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix.
• Determine the feasibility and tolerability of this regimen with the addition of amifostine in these patients.
• Determine the efficacy of these 2 regimens, in terms of improving pelvic and para-aortic tumor control and distant metastases, in these patients.

OUTLINE:

• Phase I: Patients undergo external beam radiotherapy to the pelvis and para-aortic region 5 days a week for 5 weeks. Patients also undergo either intracavitary low-dose rate (LDR) brachytherapy in 2 applications beginning within 2 weeks after completion of external beam radiotherapy at 2-3 week intervals or 6 fractions of high-dose rate intracavitary brachytherapy over 8 weeks beginning as early as week 2 of external beam radiotherapy. Patients also receive cisplatin IV over 1 hour weekly for 6 weeks concurrently with external beam radiotherapy and once with LDR brachytherapy. Phase II proceeds only if toxicity in phase I is within expected parameters.
• Phase II: Patients receive external beam radiotherapy, brachytherapy, and cisplatin as in phase I. Patients also receive amifostine subcutaneously daily just before external beam radiotherapy and cisplatin. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-66 patients (27 for phase I and 13-39 for phase II) will be accrued for this study within 12-30 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• 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

Arizona
      Foundation for Cancer Research and Education, Phoenix,  Arizona,  85013,  United States; Recruiting

Study chairs or principal investigators

William Small, MD,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000068472; RTOG-C-0116; NCT00012012
Record last reviewed:  August 2004
Last Updated:  December 6, 2004
Record first received:  March 3, 2001
ClinicalTrials.gov Identifier:  NCT00012012
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08