Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with cancer of the esophagus.

Detailed Description
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OBJECTIVES: I. Estimate the maximum tolerated dose and recommend a phase II dose for paclitaxel (TAX) when administered as a 96-hour intravenous infusion with a weekly fixed dose of intravenous cisplatin (CDDP) during concurrent radiotherapy for patients with localized esophageal cancer. II. Estimate the response rate of patients treated with 2 courses of TAX/CDDP induction chemotherapy and the complete response rate of patients treated with TAX/CDDP and concurrent radiotherapy. III. Describe the toxic effects of TAX/CDDP prior to and during radiotherapy. IV. Describe the pharmacokinetics of TAX as a continuous infusion (CI) over 96 hours. V. Evaluate, by flow cytometry, the ability of CI TAX to block esophageal cancer cells in the G2-M phase of the cell cycle. OUTLINE: After the MTD of TAX is reached on Part A, new patients are entered on Part B. The following acronyms are used: CDDP Cisplatin, NSC-119875 EBRT External-beam radiotherapy TAX Paclitaxel (Bristol-Myers), NSC-125973 PART A: Radiotherapy plus 2-Drug Combination Chemotherapy. EBRT using megavoltage equipment (>/= 10 MV recommended; electron boost allowed for subclavicular fossae); plus TAX/CDDP. PART B: 2-Drug Combination Induction Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy. TAX/CDDP; followed by EBRT as in Part A; plus TAX/CDDP. PROJECTED ACCRUAL: At least 3 patients/dose will be entered on Part A (up to 24 patients) and 3-6 patients on Part B.

Official Title
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A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: chemotherapy
* Drug: cisplatin
* Drug: paclitaxel
* Radiation: low-LET electron therapy
* Radiation: low-LET photon therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed epidermoid carcinoma or adenocarcinoma of the esophagus eligible for potentially curative radiotherapy Disease in one of the following categories: Newly diagnosed Locoregional failure after prior resection with curative intent Positive microscopic margin after palliative resection of all gross disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial invasion on bronchoscopy, including tracheoesophageal fistula PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

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: chemotherapy|nan|
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|
|Radiation: low-LET electron therapy|nan|
|Radiation: low-LET photon 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 I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus