Trial Information

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

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.