Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2018 |
| Start Date: | November 2007 |
| End Date: | December 2011 |
A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
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.
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.
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.
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.
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
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