Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: * Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin. * Compare the duration of response, time to progression, and survival of patients treated with these regimens. * Characterize and compare the toxicities of these regimens. * Determine the recommended phase III dose of erlotinib hydrochloride. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 3. * Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and carboplatin as in arm I. In both arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
