Status:
WITHDRAWN
A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Lung Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will have surgery to remove the tumor. The main purpose of this study is to study how safe and suitable treatment ...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all histologies will be allowed to enroll.
- Patients with Stage IA to IIIA disease
- ECOG Performance Status 0-1
- Measurable disease by RECIST 1.1 criteria
- Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
- Total bilirubin ≤1.5 mg/dl, SGOT (AST) and SGPT (ALT)≥ 3 x ULN
- Serum creatinine ≤ 1.5 mg/dl
- Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved.
- A signed informed consent document (ICD)
- Patients 18 years or older
- Able and willing to take oral medications
Exclusion
- Known preexisting lung disease.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
- Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade ≥2 diarrhea of any etiology.
- Baseline (\<1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
- Patients may not be receiving any other investigational agents.
- History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib or BIBW 2992
- Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant (positive pregnancy test) or lactating
- Inability to comply with study and/or follow-up procedures
- Patients who are not surgical candidates or refuse surgery
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01480141
Start Date
January 1 2012
End Date
August 1 2012
Last Update
March 26 2013
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425