Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer
I. To determine if this regimen improves the time-to-progression for patients with advanced
non-small cell lung cancer (NSCLC) compared to historical controls.
I. To assess response rate and median survival. II. To evaluate tumor biomarkers that could
predict response and survival for patients treated with this regimen including endothelial
growth factor receptor (EGFR) expression, EGFR Fluorescence in situ hybridization (FISH),
and k-ras mutations.
III. To evaluate genetic polymorphisms as markers of response and survival for patients
treated with this regimen including polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1.
Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 1 hour
on day 1, and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks
for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2
weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive
erlotinib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or
After completion of study treatment, patients are followed every 3 months for 1 year and
every 6 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|