combination chemotherapy plus radiation therapy in treating patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: 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. purpose: phase ii trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have 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.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction * potentially resectable disease * no malignant celiac node involvement * no cervical esophageal carcinoma patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,800/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast no greater than 3 times uln renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min other: * no other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no significant medical or psychiatric illness that would preclude study * not pregnant or nursing * fertile patients must use effective contraception during and for at least 3 months after study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for esophageal cancer endocrine therapy: * not specified radiotherapy: * no prior thoracic radiotherapy surgery: * see disease characteristics * no prior surgical resection of esophageal tumor

Keywords: stage 0 esophageal cancer stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus