Phase 2
N=43
Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00720304 ↗Enrolled (actual)
43
Serious AEs
27.9%
Results posted
Aug 2024
Primary outcome: Primary: Percent of Participants With Disease-Free Survival (DFS) at 3 Years — 69.5 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); erlotinib hydrochloride (Drug); fluorescence in situ hybridization (Genetic); polymerase chain reaction (Genetic); immunoenzyme technique (Other); immunohistochemistry staining method (Other); laboratory biomarker analysis (Other); pharmacological study (Other); therapeutic conventional surgery (Procedure); intensity-modulated radiation therapy (Radiation); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Disease-Free Survival (DFS) at 3 Years |
69.5 | — |
| PRIMARY Time to Progression (TTP) |
— | — |
| SECONDARY Response Rate (Complete Response, Partial Response, Stable Disease, and Disease Progression) |
— | — |
| SECONDARY Overall Survival (OS) |
81 | — |
| SECONDARY Number of Participants With Acute Grade III/IV Treatment-related Toxicities |
24; 2; 3; 14; 15; 4 | — |
| SECONDARY Percent of Participants With Local Failure-free Survival |
90 | — |
| SECONDARY Percent of Participants With Regional Failure-free Survival |
87.1 | — |
| SECONDARY Percent of Participants With Locoregional Failure-free Survival |
82.4 | — |
| SECONDARY Percent of Participants With Distant Metastasis-free Survival |
83.7 | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the head and neck
- Stage III or IV disease
- No distant metastatic disease
- Measurable disease (according to RECIST)
- No salivary gland and paranasal sinus squamous cell carcinoma
- No known brain metastases or direct cerebral invasion by tumor
- Intracranial extension (without cerebral involvement) may be allowed
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥10 g/dL
- Total bilirubin normal
- Alkaline phosphatase AND AST and ALT meeting the following criteria:
- Alkaline phosphatase normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN AND AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST and ALT normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No clinically significant heart disease including any of the following:
- NYHA class III or IV heart disease
- Significant arrhythmias requiring medication
- Symptomatic coronary artery disease
- Myocardial infarction within the previous six months
- Second- or third-degree heart block or bundle-branch block
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride or docetaxel, including other drugs formulated with polysorbate 80
- No pre-existing peripheral neuropathy ≥ grade 2
- No uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would preclude compliance with study requirements
- No HIV positivity
- No other prior malignancy except for any of the following:
- Squamous cell or basal cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Cancer that was treated more than 5 years ago and the patient has remained disease-free
- Not poorly compliant
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or investigational antitumor drug
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00720304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.