OBJECTIVES:

Primary

• Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.
• Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.

Secondary

• Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
• Determine the site of recurrence, local versus distant, in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.

Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-24 months.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal

Renal

• 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

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic or abdominal radiotherapy

Surgery

• Not specified

Other

• No prior therapy for this malignancy