Esophageal Cancer
Conditions
Keywords
adenocarcinoma of the esophagus, stage II esophageal cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy. Secondary * Determine disease-free survival and time to disease recurrence in patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years.
Interventions
DRUGgefitinib
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Survival time | Up to 5 years |
| Disease-free survival | Up to 5 years |
| Time to disease recurrence | Up to 5 years |
| Time to treatment failure | Up to 5 years |
| Quality of life | Up to 5 years |
Countries
United States
Outcome results
None listed