Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
- Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and
concurrent external beam multifield radiotherapy in patients with locally advanced
carcinoma of the esophagus or gastroesophageal junction.
- Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in
this regimen in this patient population.
- Evaluate the complete response rate in these patients to one course of induction
chemotherapy followed by concurrent chemotherapy and radiotherapy.
OUTLINE: This is a dose escalation study of irinotecan.
Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by
irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients
begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22,
and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
Primary Purpose: Treatment
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|