Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy 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.
OBJECTIVES:
I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.
II. Assess the time to disease progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.
Inclusion Criteria:
Histologically confirmed surgical stage III or IV endometrial cancer
Any stage clear or serous papillary endometrial cancer
Positive para-aortic lymph nodes allowed
Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
No recurrent disease
No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
Performance status - GOG 0-2
Absolute neutrophil count greater than 2,000/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 3 times ULN
Creatinine no greater than 1.5 times ULN
No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
No prior chemotherapy
No prior radiotherapy
See Disease Characteristics
No more than 8 weeks since prior surgery
No prior anticancer therapy that would preclude study