combination chemotherapy plus radiation therapy in treating patients with esophageal cancer

Conditions: Esophageal Cancer; Gastric 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. combining chemotherapy with radiation therapy may kill more tumor cells. purpose: phase i trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.

objectives: * determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and concurrent external beam multifield radiotherapy in patients with locally advanced carcinoma of the esophagus or gastroesophageal junction. * determine the maximum tolerated dose and the recommended phase ii dose of irinotecan in this regimen in this patient population. * evaluate the complete response rate in these patients to one course of induction chemotherapy followed by concurrent chemotherapy and radiotherapy. outline: this is a dose escalation study of irinotecan. patients receive induction chemotherapy with cisplatin iv over 30 minutes followed by irinotecan iv over 30 minutes on days 1, 8, 15, and 22. following 2 weeks of rest, patients begin chemoradiation. patients receive cisplatin and irinotecan as above on days 1, 8, 22, and 29 and radiotherapy once daily 5 days a week for 5-6 weeks. cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 3-24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction * t1, n1, m0 or t2-4, nx, m0 * no supraclavicular or celiac lymph nodes * previously untreated, newly diagnosed tumors or * prior resection without adjuvant therapy with local regional failure * positive microscopic margin on resection of all gross disease allowed provided no metastatic disease * no positive malignant cytology of the pleura, pericardium, or peritoneum * no biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% or * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9.0 g/dl hepatic: * bilirubin no greater than 1.5 mg/dl * no known gilbert's disease renal: * creatinine no greater than 1.5 mg/dl * no hypercalcemia cardiovascular: * no new york heart association class iii or iv heart disease * no myocardial infarction within the past 6 months * no uncontrolled hypertension other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease) * no other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix * no history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication * no other concurrent medical or psychiatric condition or disease that would preclude study entry prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for esophageal cancer including adjuvant chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy for esophageal cancer including adjuvant radiotherapy * no prior mantle, chest, pelvic, or hemibody radiotherapy surgery: * see disease characteristics other: * no concurrent prochlorperazine on day of irinotecan administration

Keywords: stage ii gastric cancer stage iii gastric cancer stage ii esophageal cancer stage iii esophageal cancer adenocarcinoma of the stomach squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus