Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
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.
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
- Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Degree of dysphagia relief [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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|