Esophageal Cancer Clinical Trial
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Summary
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Full Description
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride).
II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug.
IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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
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There is 1 Location for this study
New York New York, 10065, United States
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