Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Head and Neck Cancer
Drug: erlotinib hydrochloride
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1 [ Designated as safety issue: Yes ]
- Recommended phase II dose at the end of course 1 [ Designated as safety issue: Yes ]
- Correlative studies (archival and prospective) at accrual completion [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and neck.
- Determine the toxicity of this drug in these patients.
- Determine the effects of this drug on plasma and urinary angiogenic factors (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and basic fibroblast growth factor levels) in these patients.
- Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone.
- Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079053
|London Regional Cancer Program|
|London, Canada, N6A 4L6|
|CHUM - Hopital Notre-Dame|
|Montreal, Canada, H2L 4M1|
|Study Chair:||Denis Soulieres, MD, MSC||CHUM - Hotel Dieu Hospital|