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A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Medical University of South Carolina (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01480141
Collaborator
Boehringer Ingelheim (Industry)
0
Enrollment
1
Location
1
Arm
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BIBW 2992 (Afatinib)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm Study

Single arm trial where all patients will be treated with afatinib until the day of surgery and for a minimum of two weeks. Patients will receive treatment with afatinib 40mg orally daily.

Drug: BIBW 2992 (Afatinib)
Patients will receive treatment with afatinib 40mg orally daily for a minimum of 2 weeks

Outcome Measures

Primary Outcome Measures

  1. Feasibility [30 days post operative care]

    The primary endpoint will demonstrate feasibility of neoadjuvant treatment of BIBW 2992 in patients with early stage (IA to IIIA) NSCLC awaiting surgical resection. Feasibility will be assessed based on the ability to complete the treatment for each patient. For our feasibility endpoint we will declare the treatment "completed" if a patient completes at least 14 days of treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.

Secondary Outcome Measures

  1. Safety and Efficacy [30 post operative care]

    The secondary objective is to determine whether pre-operative BIBW 2992 treatment affects metabolic tumor labeling, as measured by PET-CT scanning. We will measure the absolute and the percentage change in SUV from baseline to follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • Boehringer Ingelheim

Investigators

  • Principal Investigator: George Simon, MD, Medical University of South Carolina Hollings Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
George R. Simon, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01480141
Other Study ID Numbers:
  • 101596
First Posted:
Nov 28, 2011
Last Update Posted:
Mar 26, 2013
Last Verified:
Sep 1, 2012
Additional relevant MeSH terms:
Lung Neoplasms
Afatinib

Study Results

No Results Posted as of Mar 26, 2013