Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer
This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride may kill more tumor cells
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
every 6 months for 2 years.
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