Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer

Description

This study will examine the effectiveness of a drug called Tarceva (erlotinib) giving prior to surgery in lung cancer patients. To be eligible for the study patients must have stage III Non-Small Cell Lung Cancer with EGFR mutation. Eligible patients will take Tarceva® (erlotinib) at a dose of 150 mg daily for approximately two months. After 2 months of erlotinib treatment, patients will have a PET/CT scan to determine whether they are responding to the treatment (i.e. whether or not the tumor shrunk or remains stable) or not. After the treatment patients will then be evaluated by a surgeon for surgical removal of the remaining tumor. Treatment after the surgery will be determined by the treating physician and it will be influenced by the response to treatment with Tarceva (erlotinib). A total of 55 patients with will take part in this multi-institution study.

Study Start Date

November 2013

Estimated Completion Date

July 2016

Interventions

  • Drug: Erlotinib Hydrochloride
  • Procedure: therapeutic conventional surgery
  • Other: Laboratory Biomarker Analysis
  • Drug: Tarceva (erlotinib)
  • Other: laboratory biomarker analysis
  • Procedure: Therapeutic Conventional Surgery
  • Drug: erlotinib hydrochloride

Specialties

  • Pulmonology: Clinical Pharmacology,Lung/Thoracic Oncology
  • Oncology: Lung/Thoracic Oncology,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Study ID

Albert Einstein College of Medicine of Yeshiva University -- EVENT

Status

Unknown

Trial ID

NCT01857271

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

55

Sponsor

Albert Einstein College of Medicine of Yeshiva University

Inclusion Criteria

  • Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer within 4 weeks of registration.
  • Activating mutation in EGFR oncogene
  • No prior chemotherapy or radiation for lung cancer.
  • Patients may be potentially resectable or unresectable.
  • Stage III A or B disease, including no distant metastases
  • based on following diagnostic workup: 1. History/physical examination prior to registration. 2. CT Scan of the chest or PET Scan within 28 days of study entry 3. CT Scan of abdomen or MRI of abdomen or Pet Scan within 28 days of study entry 4. An MRI of the brain or Head CT Scan with contrast within 28 days of study entry 5. Total body PET scan within 28 days of study entry 6. Mediastinoscopies are highly recommended.
  • Patients must have measurable or evaluable disease.
  • ECOG Performance Status 0-2.
  • Age > 18.
  • CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: 1. Absolute neutrophil count (ANC) >1,500 cells/ul 2. Platelets > 100,000 cells/ul 3. Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.) 4. Serum creatinine < 1.5 x ULN 5. Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN) 6. AST and ALT < 2.5 x the ULN 7. Women of childbearing potential must have: 1. A negative serum or urine pregnancy test (sensitivity 25IU HCG/L) within 72 hours prior to the start of study drug administration 2. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
  • Ability to take oral medication
  • Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria

  • Pleural or pericardial effusion a. Pleural effusions allowed if one of the following conditions are met: 1. Negative cytology after adequate sampling by thoracentisis 2. Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
  • Severe, active co-morbidity, defined as follows: 1. Cardiac Symptoms
  • any of the following should be considered for exclusion: 1. Uncontrolled angina, congestive heart failure or MI within (6 months) 2. Diagnosed congenital long QT syndrome 3. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) 4. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) 2. History of significant bleeding disorder unrelated to cancer, including: 1. Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) 2. Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) 3. Ongoing or recent (3 months) significant gastrointestinal bleeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
  • Women who: 1. are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or 2. have a positive pregnancy test at baseline, or 3. are pregnant or breastfeeding

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Albert Einstein College of Medicine - Bronx, New York 40.3 miles Haiying Cheng 718-405-8404 hcheng@montefiore.org
Columbia University Medical Center - New York, New York 44.8 miles None None None
Weill Cornell Medical College - New York, New York 50.7 miles Ronald Scheff MD 646-962-2066 None

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