Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Esophagus
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction Metastatic or surgically unresectable disease Measurable disease outside of primary tumor At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease No known brain metastases or carcinomatous meningitis Must consent to having tumor tissue tested for epidermal growth factor receptor status Performance status-Karnofsky 70-100% Life expectancy of greater than 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) no greater than 2 times ULN Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL No symptomatic hypercalcemia No symptomatic congestive heart failure No unstable angina pectoris No ventricular arrhythmia No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No other concurrent disease that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior cetuximab No more than 1 prior chemotherapy regimen for advanced or metastatic disease One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease At least 3 weeks since prior chemotherapy No concurrent investigational or commercial chemotherapy At least 3 weeks since prior radiotherapy No prior erlotinib-related compounds or compounds of similar biologic or chemical components No prior EGFR-targeting compounds (e.g., gefitinib) No other concurrent investigational agents No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.