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| Tracking Information | |||||
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| First Received Date ICMJE | September 6, 2002 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | June 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Major response rate (complete and partial response) [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Major response rate (complete and partial response) | ||||
| Change History | Complete list of historical versions of study NCT00045526 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer | ||||
| Official Title ICMJE | Phase II Study Of OSI-774 In Advanced Esophageal Cancer | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Active Control | ||||
| Condition ICMJE | Esophageal Cancer | ||||
| Intervention ICMJE | Drug: erlotinib hydrochloride | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00045526 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000256601, MSKCC-02035, NSC-718781, NCI-5445 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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