First Line Gefitinib by FDG-PET Metabolic Response

• Status: Unknown status
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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 information at the time of diagnosis, because it requires tumor tissue and some time period for EGFR examination. So, investigators develop a protocol of 1st line gefitinib treatment for NSCLC according to FDG-PET response. If a patient shows 20% or more decrease of peak standard uptake value (SUV) after 1 week's gefitinib treatment, he or she will be continued the treatment. If a patient shows less than 20% decrease of SUV, he or she will be switched to other chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: AstraZeneca
• Treatments: Gefitinib

Criteria

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.