Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer

Brief Summary

Detailed Description

OBJECTIVES: * Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy. * Determine the complete and partial responses in patients treated with this regimen. * Assess the toxicity of this regimen in these patients. * Determine the optimal dose of paclitaxel when administered in this regimen in these patients. * Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses. Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks. At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy. Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

Primary Outcomes

Not specified