Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx
About this trial
This is an interventional treatment trial for Recurrent Salivary Gland Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria: Recurrent Metastatic Locally advanced and determined to be incurable by surgery or radiotherapy Measurable disease No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas level greater than 50 mm Hg No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren'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 (Schirmer test or similar tear production test) Able to take oral medication No requirement for IV alimentation No active peptic ulcer disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant traumatic injury within the past 21 days No prior allergic reactions to compounds of similar chemical or biological composition to study drugs No grade 2 or greater persistent peripheral neuropathy No other concurrent uncontrolled illness that would preclude study participation No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No prior immunotherapy for head and neck cancer No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting No more than 1 prior chemotherapy regimen for metastatic disease No prior docetaxel (phase II only) More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior hormonal therapy for head and neck cancer Prior external beam radiotherapy allowed At least 4 weeks since prior radiotherapy and recovered More than 21 days since prior major surgery No prior surgery affecting gastrointestinal absorption No prior epidermal growth factor receptor-targeting therapy No other concurrent investigational agents No other concurrent anticancer therapies or agents No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Arm I
PHASE I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients receives erlotinib at the MTD. PHASE II: Patients receive erlotinib at the MTD and docetaxel as in phase I.