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| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2006 | ||||
| Last Updated Date | May 23, 2008 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Relationship between response rate and number of CA repeats in intron 1 of the EGFR [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Relationship between response rate and number of CA repeats in intron 1 of the EGFR | ||||
| Change History | Complete list of historical versions of study NCT00281866 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 Metastatic and/or Recurrent Head and Neck Cancer | ||||
| Official Title ICMJE | Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) | ||||
| Brief Summary | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent and/or metastatic head and neck cancer. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to genotype of intron 1 of the epidermal growth factor receptor (16/16 vs 16/20 or 20/20). Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized | ||||
| Condition ICMJE | Head and Neck 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 | ||||
| Estimated Enrollment ICMJE | 37 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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, Spain | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00281866 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000452784, JHOC-J0520, JHOC-05042801 | ||||
| Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2007 | ||||
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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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