RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.
Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one
drug and combining chemotherapy with interferon alfa, surgery, and/or radiation therapy may
kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and
interferon alfa followed by surgery and/or radiation therapy in treating patients who have
stage I, stage II, or stage III esophageal cancer.
OBJECTIVES: I. Determine response rates, duration of response, and performance status in
patients with stage I-III esophageal cancer after treatment with cisplatin, fluorouracil,
interferon alfa, and leucovorin calcium. II. Determine toxicities of this regimen in these
patients. III. Determine relapse and survival rates in this patient population treated with
this regimen. IV. Determine response rates, duration of response, performance status, and
relapse and survival rates for inoperable candidates in this patient population treated with
this regimen followed by radiotherapy. V. Determine the toxicities of this regimen followed
by radiotherapy in these patients. VI. Evaluate recurrence following this treatment regimen
in this patient population. VII. Compare roentgenographic and ultrasound responses to
histopathologic responses with this regimen in this patient population. VIII. Evaluate the
effects of this regimen and its relation to the ability to achieve negative surgical margins
and evaluate the extent of multifocality, nodal disease, tumor size, and tumor grade. IX.
Determine the incidence of perioperative complications following this regimen, including
surgical as well as operative time, blood loss, perioperative transfusions, and length of
OUTLINE: Patients receive leucovorin calcium IV continuously on days 1-5.5, interferon alfa
subcutaneously daily on days 1-6, cisplatin IV over 6 hours on day 1, and fluorouracil IV
continuously on days 1-5. Treatment continues every 21 days for 3 courses in the absence of
unacceptable toxicity. Approximately 4 weeks after chemotherapy, esophagectomy is performed
in patients without evidence of locally advanced unresectable esophageal cancer or distant
metastases. Patients determined to have residual disease following esophagectomy will be
considered for radiotherapy. Patients not undergoing esophagectomy receive chemoradiotherapy
21-28 days after completion of initial chemotherapy. Patients receive oral hydroxyurea every
12 hours on days 0-5 and fluorouracil IV continuously on days 1-5. Patients undergo
radiotherapy to esophagus daily on days 1-5. Treatment continues every 14 days for 7 courses
in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I-III squamous cell
carcinoma or adenocarcinoma of the esophagus and gastro-esophageal junction
Unidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
At least 270 days Hematopoietic: WBC greater than 3,000/mm3 Granulocyte count greater than
1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, alkaline
phosphatase, and SGOT no greater than 2 times upper limit of normal (ULN) Renal:
Creatinine less than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular:
No serious cardiovascular disease that would preclude study Other: No prior or concurrent
malignancy within past 5 years except nonmelanoma skin cancer No serious chronic medical
illness that would preclude study No acute or chronic unresolved infection Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: