Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Esophageal Cancer Gastric Cancer

Interventions

cisplatinDRUG

irinotecan hydrochlorideDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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