Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
This study has been completed.
Sponsor:
Institut Claudius Regaud
Collaborator:
Hoffmann-La Roche
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00144976
First received: September 2, 2005
Last updated: May 9, 2008
Last verified: May 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2005 | ||||
| Last Updated Date | May 9, 2008 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00144976 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma | ||||
| Official Title ICMJE | Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up. | ||||
| Brief Summary | The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma. |
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| Detailed Description | Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Head and Neck Neoplasms | ||||
| Intervention ICMJE | Drug: Tarceva
Tarceva will be administered at dosage 150 mg od one hour before or two hours after meat. Patients will receive Tarceva between 18 and 28 days.
Other Name: erlotinib |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00144976 | ||||
| Other Study ID Numbers ICMJE | 03 VADS 01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Jean-Pierre DELORD, Institut Claudius Regaud | ||||
| Study Sponsor ICMJE | Institut Claudius Regaud | ||||
| Collaborators ICMJE | Hoffmann-La Roche | ||||
| Investigators ICMJE |
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| Information Provided By | Institut Claudius Regaud | ||||
| Verification Date | May 2008 | ||||
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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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