Status:
UNKNOWN
First Line Gefitinib by FDG-PET Metabolic Response
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
When considering 1st line gefitinib treatment for NSCLC, the investigators need epidermal growth factor receptor (EGFR) mutational status of the tumor. But most patients do not give us such informatio...
Detailed Description
Gefitinib has anti-tumor activity as a result of EGFR tyrosine kinase inhibition, reducing multiple downstream signaling processes that activate cell proliferation and other cell responses, including ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- More than 18 years of age
- Advanced or metastatic adenocarcinoma of the lung. Non-smoking or light smoking patients (less than 10 PY smoking and more than 10 years of ex-smoking period) are preferred to enrich the patients with clinical response to gefitinib.
- Chemonaive patients.
- At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or and which is suitable for accurate repeated measurements.
- ECOG PS 0-2
- Patients with tissue for the detection of EGFR mutation
- At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
- Patients must have adequate hematologic, renal and liver function as defined by Hb \> 9g/dL, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dL, and AST (SGOT) and/or ALT (SGPT) \< 5 x UNL (upper normal limit).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Written and voluntary informed consent understood, signed and dated.
- Exclusion criteria
- Symptomatic brain metastasis. Brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- Major surgery within 3 weeks prior to study enrollment.
- Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
- Past medical history of interstitial lung diseas, drug induced interstitial disease, radiation pneumonitis which required steroid treatment or any active interstitial lung disease.
- Pre-existing idiopathic pulmonary fibrosis on CT scans on baseline.
- Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) \< 70mmHg.
- Uncontrolled diabetes mellitus and FBS \> 150mg/dL.
- Severe medical illness or active infection that would impair the ability to receive gefitinib.
- Pregnancy or breast feeding.
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01510990
Start Date
April 1 2012
End Date
November 1 2015
Last Update
January 29 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736