Oxaliplatin, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic esophageal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Gefitinib; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction

• Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound

• Stage T2, N0 disease and beyond

• Bulk of tumor must be in the esophagus of patients with GE junction tumor

• Bronchoscopy is required if primary esophageal tumor is < 26 cm from the incisors

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• At least 4 months

Hematopoietic

• WBC ≥ 3,000/mm^3

• Granulocyte count ≥ 1,500/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin normal

• ALT and AST ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Not specified

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Pulmonary

• No clinically active interstitial lung disease

• Patients with chronic stable asymptomatic radiographic changes are eligible

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation

• No peripheral neuropathy ≥ grade II

• No severe hypersensitivity to gefitinib or any of its excipients

• No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy

• No active or ongoing infection

• No other uncontrolled illness

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent colony-stimulating factors during course 1 of study therapy

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• Concurrent steroid therapy allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior non-approved or investigational drugs

• No concurrent administration of any of the following:

• Phenytoin

• Carbamazepine

• Rifampin

• Barbiturates

• Highly-active antiretroviral therapy (HAART)

• Hypericum perforatum (St. John's wort)

• No other concurrent investigational agents or therapy