Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 2008-06-01
• 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. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cisplatin; Gefitinib; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus

• AC of the gastroesophageal junction allowed

• Tumor must be considered surgically resectable (T1-3, NX)

• No early-stage cancer (T1, N0)

• The following lymph node (LN) criteria are considered acceptable:

• Regional thoracic LN metastases (N1)

• LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan

• Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan

• No distant metastases (M0)

PATIENT CHARACTERISTICS:

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Hemoglobin ≥ 9.0 g/dL

• Creatinine clearance ≥ 50 mL/min

• Creatinine serum level ≤ CTC grade 2

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• AST < 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No known severe hypersensitivity to gefitinib or any of its excipients

• No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease

• No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina

• No New York Heart Association class III or IV heart disease

• No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix

• No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation

• No evidence of any significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for esophageal cancer

• No prior radiotherapy that would overlap the study treatment fields

• Recovered from prior major surgery

• No nonapproved or investigational drugs within the past 30 days

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