A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | January 2012 |
| End Date: | January 2015 |
| Contact: | Jennifer Philp |
| Email: | philpj@musc.edu |
| Phone: | 843-792-6429 |
A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC
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 with Afatinib is in participants before surgery to remove the tumor.
Another goal of the study is to see if treatment with Afatinib affects the growth and
activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug
Administration) and is experimental.
In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth
Factor (EGF). This is a protein found in the body which binds to the cell wall to sites
called receptors and stimulates cell growth. Some cells have too many receptors and
uncontrolled growth and because of this, develop into a cancer tumor. There are several
other cancer drugs that bind to these receptors to slow or stop cancer growth such as
Gefitinib and erlotinib which are FDA approved and used for the treatment of NSCLC.
The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may
be a candidate for the treatment of NSCLC and a variety of early stage cancers.
Participants in this study will take Afatinib by mouth, in pill form, for at least 14 days
before having their scheduled surgery to remove their cancer tumor. Participants will be
observed for side effects and followed for 30 days after surgery to assess the results after
surgery.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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