A Phase II Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, Erlotinib, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Percent of Participants With Disease-Free Survival (DFS) at 3 Years
Study Overview
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with docetaxel and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well erlotinib given together with docetaxel and radiation therapy works in treating patients with stage III or stage IV squamous cell carcinoma of the head and neck.
Detailed Description
OBJECTIVES:
Primary
- Determine the time to progression in patients with locally advanced squamous cell carcinoma of the head and neck treated with erlotinib hydrochloride in combination with docetaxel and radiotherapy.
Secondary
- Determine objective response rate, locoregional control rate, duration of response, patterns of failure, and overall survival in patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
- Determine the dose and effect of this treatment on biologic correlates in tumor tissue and/or surrounding mucosa.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
oral erlotinib hydrochloride
Intervention: docetaxel (Drug)
oral erlotinib hydrochloride
Intervention: erlotinib hydrochloride (Drug)
oral erlotinib hydrochloride
Intervention: fluorescence in situ hybridization (Genetic)
oral erlotinib hydrochloride
Intervention: polymerase chain reaction (Genetic)
oral erlotinib hydrochloride
Intervention: immunoenzyme technique (Other)
oral erlotinib hydrochloride
Intervention: immunohistochemistry staining method (Other)
oral erlotinib hydrochloride
Intervention: laboratory biomarker analysis (Other)
oral erlotinib hydrochloride
Intervention: pharmacological study (Other)
oral erlotinib hydrochloride
Intervention: therapeutic conventional surgery (Procedure)
oral erlotinib hydrochloride
Intervention: intensity-modulated radiation therapy (Radiation)
oral erlotinib hydrochloride
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
Percent of Participants With Disease-Free Survival (DFS) at 3 Years
Time Frame: 3 yrs after treatment
Percent of participants with Disease-Free survival (DFS) at 3 years. Assessed from date of treatment to date of death or date of disease progression, and to date of last follow-up for those still alive and progression free. Disease-free Survival percentages were calculated using Kaplan-Meier estimates.
Time to Progression (TTP)
Time Frame: 3 yrs after treatment
Time from start of treatment to first documented occurrence of progressive disease (PD). PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Secondary Outcomes
- Percent of Participants With Regional Failure-free Survival(At 3 years)
- Percent of Participants With Locoregional Failure-free Survival(At 3 years)
- Overall Survival (OS)(3 years)
- Number of Participants With Acute Grade III/IV Treatment-related Toxicities(evaluated every 2 weeks, up to 3 years)
- Response Rate (Complete Response, Partial Response, Stable Disease, and Disease Progression)(3 yrs after treatment)
- Percent of Participants With Local Failure-free Survival(At 3 years)
- Percent of Participants With Distant Metastasis-free Survival(At 3 years)