Spots Global Cancer Trial Database for Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

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Trial Identification

Brief Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Official Title: Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer

Study ID: NCT00005638

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

cisplatin

irinotecan hydrochloride

radiation therapy

Study Description

Brief 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.

Detailed Description: 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.