Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

Conditions

• Lung Cancer
• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• erlotinib — DRUG
  One tablet daily of erlotinib pills (150 mg daily) for the first 21 days. After surgery, you will be asked to take adjuvant erlotinib 150 mg po daily x 2 years.
• Pemetrexed — DRUG
  pemetrexed 500 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
• Cisplatin — DRUG
  cisplatin 75 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
• Resection — PROCEDURE

Study Details

The purpose of this study is to try to improve the odds that your cancer may be cured. Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some patients with non-small cell lung cancer. Many different types of cancer cells, including your type of lung cancer, have a protein on their surface called the epidermal growth factor receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking this receptor and depriving the cancer cells of this message to grow and multiply. In this research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if the combination works better than chemotherapy alone. The main purpose of this research is to find out the good and bad effects that the combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients with early stage non-small cell lung cancer before surgery. A secondary purpose is to find out the good and bad effects that occur when erlotinib is given to patients after surgery for 2 years.

Key Dates

First listed

Dec 20, 2007

Start date

Nov 30, 2007

Status verified

Dec 2017

Primary completion

Dec 31, 2011

Completion

Dec 31, 2011

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients With Stage IB-IIIA NSCLC With EGFR Mutations
  This is a open label, single center, phase II trial for patients with clinical stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable tumors that harbor EGFR activating mutations. Patients will receive erlotinib x 3 weeks prior to initiation of concurrent erlotinib and chemotherapy.

Primary Outcome Measure

Number of Patients With Pathologic Complete Response Rate [ Time Frame: Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months. ]

Locations (1)

Find similar trials in New York, NY

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