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

NCT ID: NCT00577707

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

Detailed Description

Chemotherapy and surgery in combination represents the standard of care for patients with resectable stage IB-IIIA NSCLC. However, the 5-year survival continues to be disappointing despite this standard of care. This study incorporates targeted therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) as part of a multimodality strategy for stage IB-IIIA resectable NSCLC tumors with a known EGFR activating mutation. The rationale for including only patients with EGFR mutations is based on recent data that reported that patients with advanced NSCLC whose tumor harbor EGFR activating mutations had an objective response rate of 71% with gefitinib compared with a 1% objective response rate in patients with EGFR wild-type tumors.

Conditions

Non Small Cell Lung Cancer; Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

erlotinib

Intervention Type: 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

Intervention Type: DRUG

pemetrexed 500 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.

Cisplatin

Intervention Type: DRUG

cisplatin 75 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.

Resection

Intervention Type: PROCEDURE

Interventions

erlotinib

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.

Intervention Type: DRUG

Pemetrexed

pemetrexed 500 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.

Intervention Type: DRUG

Cisplatin

cisplatin 75 mg/m\^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.

Intervention Type: DRUG

Resection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pathologic confirmation of NSCLC
• Patients must have previously untreated stage IB-IIIA NSCLC (T1-3N0-2M0)
• Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R, L861Q)
• Patients must be candidates for resection with curative intent
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
• Age greater or equal to 18 years
• Karnofsky performance status greater or equal to 70%
• Normal marrow function: leukocytes greater than or equal to 3,000/μl, absolute neutrophil count greater than or equal to 1,500/μl, platelets greater than or equal to 100,000/μl, hemoglobin greater than or equal to 9 gm/dl
• Adequate renal function, with creatinine less than or equal to 1.3 mg/dl or calculated creatinine clearance greater to or equal to 60ml/min by Cockroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
• Adequate hepatic function: Total bilirubin within normal limits, AST < 1.5 X UNL, alkaline phosphatase < 1.5 X UNL
• Women of childbearing age must have a negative urine or blood pregnancy test
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
• Patients must have ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Prior chemotherapy or radiation therapy, with the exception of chemotherapy for nononcologic conditions (ie, methotrexate for the treatment of rheumatoid arthritis)
• Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
• Patients must not be receiving any other investigational agents
• Any evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
• Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade 2 or higher)
• Peripheral neuropathy > grade 1
• Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.
• Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
• Women who are pregnant or breast-feeding
• Psychiatric illness or social situation that would limit compliance with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naiyer Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

07-103

Identifier Type: -

Identifier Source: org_study_id

NCT00602238

Identifier Type: -

Identifier Source: nct_alias