Erlotinib in Treating Patients With Metastatic and/or Recurrent 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 stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Metastatic and/or locally recurrent disease No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland WHO Type I squamous cell carcinoma of the nasopharynx are allowed Incurable with surgery or radiotherapy Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days PATIENT CHARACTERISTICS: ECOG performance status 0-2 Predicted life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and/or ALT ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must practice effective contraceptive measures No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer No active or uncontrolled infection or other serious illnesses or medical conditions No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered At least 14 days since prior surgery AND wound healing has occurred At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following: Hydrastis canadensis (goldenseal) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Naringenin No other concurrent anticancer therapy or other investigational agents No concurrent administration of any of the following: Phenytoin Carbamazepine Rifampicin Barbiturates Hypericum perforatum (St. John's wort) CYP3A inhibitors (e.g., itraconazole)
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Hospital Universitario 12 de Octubre