This phase I trial studies docetaxel, cisplatin, and erlotinib hydrochloride in treating patients with stage I-III non-small cell lung cancer following surgery. 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, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel, cisplatin, and erlotinib hydrochloride together may kill more tumor cells.
PRIMARY OBJECTIVES: I. To evaluate the safety/toxicity of neoadjuvant chemotherapy with cisplatin and docetaxel followed by maintenance therapy with the epidermal growth factor receptor (EGFR) inhibitor erlotinib (erlotinib hydrochloride) in patients with stage I-III non-small cell lung cancer (NSCLC) undergoing definitive treatment with surgery and/or radiation. II. To estimate the agreement in baseline to post-treatment changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue. SECONDARY OBJECTIVES: I. To evaluate the disease free survival of this therapeutic combination. II. To assess overall quality of life. III. To evaluate predictive biomarkers in early-stage NSCLC. OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride orally (PO) daily for up to 1 year. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
M D Anderson Cancer Center
Houston, Texas, United States
Rate of grade 3 or greater toxicities (hematologic or non-hematologic)
Time frame: Up to 5 years post-treatment
Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue
Agreement will be estimated using the kappa coefficient. An important aspect of this trial is to identify changes in expression of potential biomarkers between buccal smears and bronchial tissues after induction (neoadjuvant) platinum-based therapy in early-stage , resectable non-small cell lung cancers. As part of the primary outcome measures, we plan to measure the EGFR expression changes (i.e. EGFR modulation) between buccal smears and bronchial tissues after induction therapy.
Time frame: From baseline up to 5 years post-treatment
Incidence of EGFR mutations
The frequency of EGFR mutations in resected tumor specimens following neoadjuvant platinum-based therapy will be evaluated.
Time frame: Up to 5 years post-treatment
Evaluation of immune-based biomarkers
The correlation among various continuous and discrete biomarkers will be assessed first by exploratory data analysis using scatter plot matrix, bx plots, BLiP plot, and trellis plots. Correlation among continuous biomarkers will be estimated by Pearson or Spearman rank correlation coefficient. The association on discrete biomarkers will be tested by chi-square or Fisher's exact test. McNamar's test will be applied to test the change of a single discrete biomarker over time.
Time frame: Up to 5 years post-treatment
Time to progression
Estimated by Kaplan-Meier method. The Cox (proportional hazards) model will be fitted to estimate the effect of biomarker and other covariates on survival.
Time frame: Up to 5 years post-treatment
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