Retreatment of Gefitinib in the Patients With Non-small Cell Lung Cancer (NSCLC) Previously Responded to Gefitinib A Single Arm, Open Label, Phase II Study

Chonnam National University Hospital1 site in 1 country23 target enrollmentJanuary 2009

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsGefitinib retreatment

DrugsGefitinib retreatment

Overview

Phase: Phase 2
Intervention: Gefitinib retreatment
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Chonnam National University Hospital
Enrollment: 23
Locations: 1
Primary Endpoint: Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure.

Primary endpoint

to assess Disease Control Rate (Remission + Stable disease)

Secondary endpoints

to assess the progression free survival

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chonnam National University Hospital

Responsible Party

Principal Investigator

Young-Chul Kim

Professor

Chonnam National University Hospital

Eligibility Criteria

Inclusion Criteria

•Recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) stage IV or IIIB patients after chemotherapy following gefitinib failure
•Male and female patients aged over 18 years
•World Health Organization (WHO) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
•Had at least stable disease with previous Gefitinib treatment
•Had at least one anticancer agent therapy after gefitinib failure ;Following treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)- erlotinib or other TKIs should not be included in anticancer agent therapy.
•The current approved indication of Gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic NSCLC. However, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. Thus, in this trial gefitinib retreatment will be 3rd line or more.
•Measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
•Provision of written informed consent
•Life expectancy of at least 12 weeks

Exclusion Criteria

•Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
•Expected life expectancy less than 2 months
•Known severe hypersensitivity to gefitinib or any of the excipients of this product
•Any unresolved chronic toxicity greater that Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy
•As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
•Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
•Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x Upper Limit Normal (ULN) if no demonstrable liver metastases (or \>5 x in presence of liver metastases)
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
•Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
•Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks

Arms & Interventions

Gefitinib retreatment group

Gefitinib retreatment

Intervention: Gefitinib retreatment

Outcomes

Primary Outcomes

Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT

Time Frame: 8 weeks

Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).