A Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer
- To determine if dose-dense docetaxel, cisplatin, and pegfilgrastim followed by
dose-intense erlotinib hydrochloride improves the time to progression in patients with
stage IIIB or IV non-small cell lung cancer compared to historical controls.
- To assess response rate and median survival.
- To evaluate genetic polymorphisms as markers of response and survival, including
polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1, in patients treated with this
OUTLINE: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and
pegfilgrastim subcutaneously 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 oral erlotinib hydrochloride
once daily in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline for pharmacogenetic studies. Samples are examined for genetic
After completion of study treatment, patients are followed every 3 months for 1 year and
every 6 months for 2 years.
Masking: Open Label, Primary Purpose: Treatment
Time to progression
W. Jeffrey Petty, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|