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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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) ‚Č• 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Young-Chul Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

D791JL00001

NCT ID:

NCT00824746

Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Gefitinib
  • Recurrence
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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