Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Inclusion criteria

• Patients must be able to sign the informed consent document.

Exclusion criteria

• Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
• Cervical esophageal tumors,
• Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
• Prior chemotherapy or radiation.
• Patients with evidence of metastatic disease are not eligible. This includes:
• Positive malignant cytology of the pleura, pericardium or peritoneum.
• Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
• Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
• Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
• New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
• Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
• Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
• History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
• Patients with known Gilbert's Disease.
• Clinically significant hearing loss.
• Serum calcium_>12 mg/dl.
• Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
• Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
• Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.