Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
|Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Recurrent Esophageal Cancer Squamous Cell Carcinoma of the Esophagus Stage III Esophageal Cancer Stage IV Esophageal Cancer||Drug: erlotinib hydrochloride Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study Of OSI-774 In Advanced Esophageal Cancer|
- Major response rate (complete and partial response) [ Time Frame: Up to 5 years ]
- Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 5 years ]
- Degree of dysphagia relief [ Time Frame: Up to 5 years ]
- Time to progression [ Time Frame: Up to 5 years ]Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
- Overall survival [ Time Frame: Up to 5 years ]Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.
|Study Start Date:||June 2002|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Other Names:Other: laboratory biomarker analysis
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.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045526
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||David Ilson||Memorial Sloan Kettering Cancer Center|