Iressa as Second Line Therapy in Advanced NSCLC-Asia (ISTANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478049
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

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
NSCLC Drug: Gefitinib Drug: Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
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 : September 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere

Experimental: 2
Drug: Gefitinib
250 mg oral tablet
Other Names:
  • ZD1839

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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: Every Visit ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478049

Korea, Republic of
Research Site
In Cheon, Korea, Republic of
Research Site
Kyonggi-do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: SangWe Kim, MD Asan Medical Center

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00478049     History of Changes
Other Study ID Numbers: D7913L00039
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors