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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
  Given orally
• therapeutic endoscopic surgery — PROCEDURE
  Undergo surgical resection
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

First listed

Jul 12, 2004

Start date

Dec 31, 2004

Status verified

Jun 2013

Primary completion

Apr 30, 2006

Study Design

Enrollment

110 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (erlotinib)
  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.

Primary Outcome Measure

Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT [ Time Frame: Up to 5 years ]

Locations (1)

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