NCT01557959

Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adenocarcinoma of the Lung
• Adenosquamous Cell Lung Cancer
• Bronchoalveolar Cell Lung Cancer
• Large Cell Lung Cancer
• Non-small Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Given IV
BIOLOGICAL	pegfilgrastim	Given SC
DRUG	erlotinib hydrochloride	Given PO
OTHER	laboratory biomarker analysis	Optional correlative study
GENETIC	polymorphism analysis	Correlative study
OTHER	pharmacogenomic studies	Correlative study
GENETIC	genetic linkage analysis	Correlative study
DRUG	docetaxel	Given IV

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2012-03-20
• Last updated: 2018-06-29
• Results posted: 2013-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study