Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

• Status: Completed
• Trial end date: 2009-10-01
• 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.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

• Locally advanced disease

• T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement

• Celiac node involvement allowed

• No supraclavicular lymph node involvement

• Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months

• Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months

• No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy

• No positive margins at the time of prior surgery

• No measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL

Renal

• Creatinine ≤ 2 times upper limit of normal

Cardiovascular

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

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to swallow study drug

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• No prior gefitinib

• No concurrent CYP3A4 inducing agents, including any of the following:

• Carbamazepine

• Oxcarbazepine

• Modafinil

• Ethosuximide

• Griseofulvin

• Nafcillin

• Phenobarbital

• Phenylbutazone

• Phenytoin

• Primidone

• Rifampin

• Hypericum perforatum (St. John's wort)

• Sulfinpyrazone

• No concurrent antacids 4 hours before or after study drug administration