Iressa as Second Line Therapy in Advanced NSCLC-Asia

NSCLC Clinical Trial

— ISTANA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478049
• Other study ID #: D7913L00039
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2007
• Last updated: June 5, 2012
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Gefitinib
250 mg oral tablet
• Docetaxel
intravenous infusion

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors		Survival	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To compare the safety and tolerability of gefitinib and of docetaxel by Frequency and severity of adverse events (AEs) and laboratory parameters.		Every Visit	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US