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Status:

TERMINATED

Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

AstraZeneca

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: Thi...

Detailed Description

OBJECTIVES: Primary * Determine the effects of neoadjuvant gefitinib on downstream signaling pathways, including Src-Stat3, PI3K/Akt, ERK activity, and Bcl-2 family members in patients with resectab...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed resectable non-small cell lung cancer (NSCLC), meeting 1 of the following clinical staging criteria:
  • Stage IA or IB (T1-2, N0)
  • Stage II (T1-2, N1 with negative mediastinoscopy or T3, N0)
  • Stage IIIA (T3, N1 with negative mediastinoscopy)
  • Level 10 hilar nodes may be positive provided mediastinoscopy is negative
  • The following are not allowed (as evidenced by clinical staging criteria \[CT scan, positron-emission tomography (PET) scan, or mediastinoscopy):
  • Positive N2 lymph nodes (ipsilateral/subcarinal mediastinal lymph nodes)
  • Positive N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene lymph nodes)
  • T4 primary tumor (malignant pleural effusion or mediastinal invasion)
  • Symptomatic tumors (T3, N0-1) involving the superior sulcus (i.e., Pancoast tumors)
  • Measurable disease by contrast-enhanced CT scan
  • No metastatic disease (except peribronchial or hilar lymph node involvement \[N1\]) by fludeoxyglucose F 18 PET scan
  • No malignant pleural effusion by preoperative evaluation
  • Pleural effusions visible only on CT scan that are not large enough for safe thoracentesis are allowed
  • No exudative effusions (even if cytologically negative), as evidenced by any of the following:
  • Ratio of pleural fluid protein to serum protein \> 0.5
  • Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH ≥ 0.6
  • Pleural fluid LDH \> 200 IU/L
  • No superior vena cava syndrome
  • No spinal cord compression
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • WBC ≥ 4,000/mm\^3
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2 times ULN
  • Alkaline phosphatase ≤ 2 times ULN
  • Renal
  • Creatinine \< 1.5 times ULN
  • Cardiovascular
  • No uncontrolled ventricular arrhythmia
  • No myocardial infarction within the past 3 months
  • Pulmonary
  • Pre-resection FEV\_1 \> 2.0 L OR
  • Predicted post-resection FEV\_1 \> 1.0 L
  • No clinically active interstitial lung disease
  • Chronic stable asymptomatic radiographic changes allowed
  • No post-obstructive pneumonia
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide tumor biopsy pre- and post-gefitinib administration AND undergo PET scan
  • No known severe hypersensitivity to study drug or any of its excipients
  • No uncontrolled major seizure disorder
  • No unstable or uncontrolled diabetes mellitus
  • No serious infection requiring IV antibiotics
  • No grade 3 neuropathy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other unstable or serious medical condition that would preclude study treatment or surgery
  • No psychiatric disorder that would preclude giving informed consent
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow up
  • No other significant clinical disorder or laboratory finding that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior or concurrent systemic chemotherapy for NSCLC
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior or concurrent radiotherapy for NSCLC
  • Surgery
  • Recovered from prior oncologic or other major surgery
  • At least 5 years since prior resection of lung disease
  • No prior surgery for NSCLC
  • No concurrent ophthalmic surgery
  • Other
  • More than 30 days since prior non-approved or investigational drugs
  • No other concurrent therapy for NSCLC
  • No other concurrent investigational therapy
  • No concurrent use of any of the following medications:
  • Phenytoin
  • Carbamazepine
  • Barbiturates (e.g., phenobarbital)
  • Rifampin
  • Hypericum perforatum (St. John's wort)

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2009

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00104728

    Start Date

    October 1 2004

    End Date

    March 1 2009

    Last Update

    October 31 2012

    Active Locations (1)

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    H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, United States, 33612-9497