First Line Gefitinib by FDG-PET Metabolic Response

NCT01510990 | Unknown Phase 2

• 1 other identifier: AMC 2011-0858
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; Gefitinib; FDG-PET

Outcome Measures

Primary Outcomes (1)

• Objective Response rate

  The primary objective is to see the response rate of gefitinib in the patients who showed % decrease of peak SUV of main lesion 20% or more and continuously treated with gefitinib.

  one year

Secondary Outcomes (1)

• Objective response rate by EGFR mutational status

  One year

Study Arms (1)

Gefitinib

EXPERIMENTAL

After a baseline 18F FDG-PET, patients are treated with gefitinib 250mg/d as 1st line treatment for 7 days. And follow up 18F-FDG PET image is acquired after 1 week's treatment of gefitinib (with window period +/- 2 days). If % decrease of peak SUV of main lesion is 20% or more, gefitinib treatment is continued till progression, unacceptable toxicities or patient's refusal. But if % decrease of peak SUV of main lesion less than 20% or peak SUV increase, gefitinib treatment is stopped, and changed to Pemetrexed/Cisplatin chemotherapy.

Drug: Gefitinib

Interventions

Gefitinib DRUG

gefitinib 250mg/day daily

Also known as: Iressa

Gefitinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sang-We Kim, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-We Kim, M.D.

CONTACT

82-2-3010-3215; swkim@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 18, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2015
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

KR (1)