Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)

NCT00824746 | Completed Phase 2 Results

• 1 other identifier: D791JL00001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Gefitinib; Recurrence; Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

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

  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).

  8 weeks

Secondary Outcomes (2)

• Progression - Free Survival of Patients Retreated With Gefitinib

  two year

• Overall Survival

  2 years

Study Arms (1)

Gefitinib retreatment group

EXPERIMENTAL

Gefitinib retreatment

Drug: Gefitinib retreatment

Interventions

Gefitinib retreatment DRUG

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 EGFR-TKI failure.

Also known as: Iressa

Gefitinib retreatment group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-809, South Korea

Location

Related Publications (1)

• Oh IJ, Ban HJ, Kim KS, Kim YC. Retreatment of gefitinib in patients with non-small-cell lung cancer who previously controlled to gefitinib: a single-arm, open-label, phase II study. Lung Cancer. 2012 Jul;77(1):121-7. doi: 10.1016/j.lungcan.2012.01.012. Epub 2012 Feb 12.

  PMID: 22333554 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Our study has several limitations such as lack of generalizability outside a clinically and molecularly enriched population and the small number of repeat biopsies.

Results Point of Contact

• Title: Young-Chul Kim, MD, PhD
• Organization: Chonnam National University Hwasun Hospital

kyc0923@jnu.ac.kr

82-61-379-7614

Study Officials

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: Professor

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 19, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 26, 2013
• Results First Posted: February 26, 2013

Record last verified: 2013-01

Locations

KR (1)