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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079053 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: erlotinib hydrochloride Procedure: adjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 20 |
Study Start Date: | November 2003 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 8 patients are treated at that dose level.
Patients are followed at 4 weeks, every 12 weeks for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks
No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Ophthalmic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Canada, Quebec | |
Hopital Notre-Dame du CHUM | |
Montreal, Quebec, Canada, H2L 4M1 |
Study Chair: | Denis Soulieres, MD, MSC | CHUM - Hotel Dieu Hospital |
Study ID Numbers: | CDR0000353485, CAN-NCIC-HN5, ROCHE-CAN-NCIC-HN5 |
Study First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00079053 |
Health Authority: | United States: Federal Government |
stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx |
stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity salivary gland squamous cell carcinoma stage III salivary gland cancer stage IV salivary gland cancer |
Erlotinib Squamous cell carcinoma Carcinoma Epidermoid carcinoma Nasopharyngeal carcinoma Head and Neck Neoplasms Carcinoma, squamous cell |
Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Carcinoma, Squamous Cell Salivary Gland Diseases Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |