Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

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