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ISTANA: Iressa as Second Line Therapy in Advanced NSCLC-Asia

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00478049
Collaborator
(none)
163
Enrollment
4
Locations
2
Arms
41
Duration (Months)
40.8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open Label, Parallel Group, Regional, Multicenter, Phase III Study of Oral Gefitinib (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer Who Have Previously Received Platinum Based Chemotherapy (ISTANA)
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Docetaxel

Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere

    		•
    Experimental: 2

    Gefitinib

    Drug: Gefitinib
    250 mg oral tablet
    Other Names:
  • ZD1839
  • IRESSA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors [Survival]

    Secondary Outcome Measures

    1. To compare the overall objective tumor response rates between patients on gefitinib or on docetaxel by overall objective tumor response (complete response (CR) + partial response (PR)) using RECIST criteria. [Survival]

    2. To compare changes in quality of life (QoL) between patients on gefitinib or on docetaxel by QoL as measured by the FACT-L total score [Every Visit]

    3. For those patients who are symptomatic at baseline to compare improvement in symptom control between patients on gefitinib or on docetaxel by the FACT-L LCS (Functional Assessment of Cancer Therapy - Lung Lung Cancer Subscale). [Each Visit]

    4. To compare the safety and tolerability of gefitinib and of docetaxel by Frequency and severity of adverse events (AEs) and laboratory parameters. [Every Visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma.

    • WHO Performance status 0-2

    • NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy

    • Life expectancy of 12 weeks.

    Exclusion Criteria:

    • ALT/AST: >2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver.

    • Inadequate bone marrow function; Absolute neutrophil count: <1.5 x 109/L, Platelets: < 100 x 109/L

    • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin or cervical cancer in situ

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site In Cheon Korea, Republic of
    2 Research Site Kyonggi-do Korea, Republic of
    3 Research Site Seoul Korea, Republic of
    4 Research Site Suwon Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: SangWe Kim, MD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00478049
    Other Study ID Numbers:
    • D7913L00039
    First Posted:
    May 24, 2007
    Last Update Posted:
    Jun 6, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by AstraZeneca
    Non-Small Cell Lung Cancer
    Additional relevant MeSH terms:
    Docetaxel
    Gefitinib

    Study Results

    No Results Posted as of Jun 6, 2012