Status:
TERMINATED
Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage IA Non-small Cell Lung Cancer
Stage IB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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, op...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with suspicion of lung cancer without distant metastases
- Patients are scheduled to have a tissue diagnostic procedure within 3 to 5 days of pre-registration
- Patients are willing to allow collection and submission of baseline and post-therapy tumor tissue, skin and blood samples for this study
- Patients must have ECOG performance status of 0, 1, or 2
- Patients must have no psychological, familial, sociological, or geographic conditions that will interfere with medical follow-up and compliance with the study protocol
- Patients must have no prior chemotherapy or radiation therapy or no prior anti- EGFR treatment exposure
- Patients must be able to take oral medication and not have malabsorption syndrome, or prior gastrointestinal surgery that limits their absorption (i.e. requiring total parental nutrition)
- Patients must not be using phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, oxcarbazepine, rifapentine, St John's Wort, or any other CYP 3A4 enzyme-inducing agent; any use of these substances must be discontinued at least 2 weeks prior to registration
- Patients must not be taking any anti-coagulants
- Patients must not have been treated with a non-approved or investigational drug within 21 days prior to pre-registration; patients must not have serious underlying medical condition that would impair the ability of patient to receive the planned treatment
- Patients with a known hypersensitivity to OSI-774 (erlotinib) are not eligible
- Patients must have histologically confirmed NSCLC; cytologic specimens obtained by brushing, washing or needle aspiration of defined lesions will be acceptable
- Patients must have stage IA (T1N0M0), stage IB (T2N0M0), stage IIA (T1N1M0), stage IIB (T2N1M0; T3N0-1M0), or stage IIIA (T1-3N2M0) disease
- Patients with small cell component on histology specimen are not eligible
- A paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC and obtained during the diagnostic biopsy is available for submission
- Patients must be considered operable candidates and disease must be considered resectable
- Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk
- All females of childbearing potential must have a blood test or urine study within 1 week, prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
- WBC \>= 3500/mm\^3
- ANC \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Total bilirubin \< 1.5mg/dL
- SGPT and SGOT \< 3 times institution's upper limit of normal
- Serum creatinine \< 2mg/dl or creatinine clearance \>= 20 ml/min
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00087269
Start Date
December 1 2004
Last Update
June 6 2013
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215