A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer

Fecha de inicio: 1 de enero de 2000

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction Stage I-III Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors No disease outside esophagus and peri-esophageal soft tissue GE junction tumors must be confined to no greater than 2 cm into the gastric cardia Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm No recurrent disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No grade 2 peripheral neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy No other concurrent uncontrolled illness No ongoing or active infection No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No colony-stimulating factor therapy during first study course Chemotherapy: No prior chemotherapy for esophageal cancer At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for esophageal cancer At least 4 weeks since other prior radiotherapy Surgery: No prior resection or attempted resection of esophageal cancer Other: No other concurrent investigational drugs No other concurrent commercial agents or therapies for esophageal cancer No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients