NCT00087269

Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection

Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well erlotinib works in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may shrink the tumor so that it can be removed.

Detailed description

PRIMARY OBJECTIVES: I. To determine the biochemical response rate (\> 75% decrease in P-MAPK and/or P-AKT) with daily oral OSI-774 (erlotinib) for 14 consecutive days in patients with early stage, operable NSCLC. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerance of daily oral OSI-774 (erlotinib) as pre-operative treatment for early stage operable NSCLC. TERTIARY OBJECTIVES: I. To correlate antiproliferative (Ki-67, p27) and apoptotic (TUNEL assay) tumor responses to OSI-774 (erlotinib) with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 (erlotinib) for 14 days. II. Assessment of functional EGFR status: HER1, HER-2, HER3, HER4, PHER1, AKT, P-AKT, MAPK-P-MAPK, STAT-3, P-STAT-3, EGFR-III by immunohistochemistry (IHC). III. Assessment of proliferative response: Ki67 and p27 by IHC. IV. Assessment of apoptotic response: TUNEL assay. V. To study the role of the gastrin-releasing factor and estrogen receptor pathways in the sensitivity and resistance of NSCLC to OSI-774 (erlotinib). VI. To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical, biochemical, antiproliferative, and apoptotic responses. VII. To study the antitumor activity of OSI-774 (erlotinib) in NSCLC tumors heterotransplanted in nude mice after surgical resection and to investigate the sequential molecular changes associated with tumor response to OSI-774 (erlotinib) therapy. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician. Patients are followed for 5 years after study registration.

Conditions

• Stage IA Non-small Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer
• Stage IIA Non-small Cell Lung Cancer
• Stage IIB Non-small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally
PROCEDURE	therapeutic endoscopic surgery	Undergo surgical resection
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-04-01
• First posted: 2004-07-12
• Last updated: 2013-06-06

Locations

1 site across 1 country: United States