A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer
I. Determine the maximum tolerated dose of erlotinib that can be administered with chest
radiotherapy in combination with cisplatin and etoposide or carboplatin and paclitaxel in
patients with inoperable stage III non-small cell lung cancer.
II. Determine the dose-limiting toxicity of these regimens in these patients. III. Assess
the clinical response (complete response, partial response, progressive disease, or stable
disease) in patients treated with these regimens.
IV. Determine levels of tumor epidermal growth factor expression in patients treated with
OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to
1 of 2 treatment groups.
GROUP 1: Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV
over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients
undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients
receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92.
Some patients may also receive oral erlotinib once daily on days 50-112.
GROUP 2: Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and
carboplatin IV over 30 minutes on days 1 and 21. Patients receive consolidation therapy
comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57,
64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo
radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib during
concurrent chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity.
At least 12 patients from each group are treated at the MTD.
Patients are followed at 8 weeks.
PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per treatment group) will be accrued for
this study within 6-12 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
MTD defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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