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.

Condition	Treatment or Intervention	Phase
squamous cell carcinoma of the esophagus stage III esophageal cancer Adenocarcinoma of the Esophagus stage I esophageal cancer stage II esophageal cancer	Drug: cisplatin  Drug: fluorouracil  Drug: hydroxyurea  Drug: interferon alfa  Drug: leucovorin calcium	Phase II

Further Study Details: 

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 hospital stay.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven stage I-III squamous cell carcinoma or adenocarcinoma of the esophagus and gastro-esophageal junction
• Unidimensionally measurable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy
• Surgery: Not specified

--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

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States

Study chairs or principal investigators

Claudia Tellez,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067576; NU-94I1; NCI-G00-1679
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004897
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08