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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045526 |
Purpose
RATIONALE: Erlotinib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying erlotinib to see how well it works in treating patients with advanced esophageal cancer or stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Study Of OSI-774 In Advanced Esophageal Cancer |
| Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a non-randomized study. Patients are stratified according to epidermal growth factor receptor status (positive vs negative).
Patients receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction
Measurable disease outside of primary tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | David H. Ilson, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00045526 History of Changes |
| Other Study ID Numbers: | CDR0000256601, MSKCC-02035, NSC-718781, NCI-5445 |
| Study First Received: | September 6, 2002 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the esophagus recurrent esophageal cancer squamous cell carcinoma of the esophagus stage III esophageal cancer stage IV esophageal cancer |
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |