Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent metastatic squamous neck cancer occult primary, neck cancer with occult primary squamous carcinoma, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, squamous cell carcinoma of paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of sinus and nasal cavity
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus Recurrent, unresectable, and/or metastatic disease At least 1 measurable lesion At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan Lesions accessible for biopsy Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: More than 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal: No gastrointestinal tract disease resulting in malabsorption No requirement for IV alimentation No active peptic ulcer disease Inability to swallow tablets or silicon-based G-tubes allowed Ophthalmic: No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy No significant traumatic injury within the past 21 days No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed At least 6 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and recovered No prior radiotherapy to target lesion unless there is evidence of disease progression Surgery: See Disease Characteristics At least 21 days since prior major surgery No prior surgical procedure affecting gastrointestinal absorption Other: No prior EGFR-targeting therapies No prior investigational agents for recurrent or metastatic disease No concurrent combination anti-retroviral therapy for HIV infection No other concurrent investigational agents No other concurrent anticancer treatment
Sites / Locations
- Margaret and Charles Juravinski Cancer Centre
- Queen's University
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Princess Margaret Hospital
- Centre Hospitalier de l'Universite de Montreal
Arms of the Study
Arm 1
Experimental
OSI-774 and cisplatin
HNSCC patients treated in three escalating dose cohorts of daily continous oral erlotinib (OSI-774) and intermittent IV cisplatin given every 21 days