Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

OBJECTIVES:

• Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium.

OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).

Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR.

Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of endometrial cancer, including any of the following cellular types:

• Papillary serous carcinoma
• Clear cell carcinoma
• Adenocarcinoma
• Stage III or IV disease

• No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)
• Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks

• Peritoneal washings must have been collected for cytological evaluation
• Must have ≤ 1 cm residual disease after surgery

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 6 months
• WBC ≥ 3,000/mm^3
• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine < 2.0 mg/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Lactate dehydrogenase < 3 times ULN
• Gamma glutamyl transferase < 3 times ULN
• SGPT and SGOT < 3 times ULN
• Alkaline phosphatase < 3 times ULN
• No other malignant tumor within the past 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to the whole abdomen and/or pelvis/vagina
• No systemic chemotherapy within the past 5 years