Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Squamous Cell Carcinoma of the Hypopharynx
About this trial
This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck Recurrent and/or metastatic disease Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No more than 2 prior treatment regimens for recurrent or metastatic disease Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Creatinine normal Creatinine clearance > 60 mL/min Cardiac ejection fraction normal by echocardiogram or MUGA No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Able to swallow and retain oral or feeding tube-administered medication No malabsorption syndrome No requirement for IV alimentation No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib No other uncontrolled illness No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance Prior cetuximab allowed See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior cumulative anthracycline therapy ≥ 450 mg/m^2 of doxorubicin or equivalent More than 4 weeks since prior radiotherapy No prior surgical procedure affecting absorption Recovered from prior therapy Other prior epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) allowed Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR No concurrent CYP3A4 inhibitors or inducers No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.