NCT00254384

Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery

Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IA Lung Non-Small Cell Carcinoma AJCC v7
• Stage IB Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7
• Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Docetaxel	Given IV
DRUG	Erlotinib	Given PO
DRUG	Erlotinib Hydrochloride	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2005-10-05
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2005-11-16
• Last updated: 2024-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study