Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Enzyme Inhibitors; Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus

• Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)

• Stage I-III disease

• No known distant metastases

• No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)

• No supraclavicular metastases

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Adequate bone marrow function

Hepatic

• Adequate hepatic function

• No unstable or uncompensated hepatic disease

Renal

• Creatinine ≤ grade 2 by Common Toxicity Criteria

• Adequate renal function

• No unstable or uncompensated renal disease

Cardiovascular

• No unstable or uncompensated cardiac disease

Pulmonary

• No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes

• No unstable or uncompensated respiratory disease

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known hypersensitivity to gefitinib or any of the excipients

• No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix

• No evidence of severe or uncontrolled systemic disease

• No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Endocrine therapy

• Concurrent stable-dose steroids allowed

Surgery

• Recovered from any prior oncologic or other major surgery

Other

• More than 30 days since prior nonapproved or investigational drug

• No prior therapy for this or any other malignancy

• No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)