Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: irinotecan hydrochloride
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: irinotecan hydrochloride|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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