Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma… (NCT00079053) | Clinical Trial Compass
CompletedPhase 1
Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Canada19 participantsStarted 2004-03-02
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Stage III, IVA, or IVB
* Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks
* Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose
* No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:
* Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
* Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
* Tumor tissue samples available for EGFRvIII mutation analysis
* No known brain metastasis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* ALT/AST \< 2 times upper limit of normal (ULN)
* Bilirubin \< ULN (unless due to Gilbert's syndrome)
Renal
* Creatinine \< 1.5 times ULN
Cardiovascular
* No myocardial infarction within the past year
* No cardiac ventricular arrhythmias requiring medication
* No history of cardiac disease
* No uncontrolled high blood pressure
* No unstable angina
* No congestive heart failure
Ophthalmic
* No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunc…
What they're measuring
1
Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1