Clinical trial NCT00478049: Iressa as Second Line Therapy in Advanced NSCLC-Asia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSCLC
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors
timeFrame: Survival
Secondary outcomes:
measure: 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.
timeFrame: Survival
measure: 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
timeFrame: Every Visit
measure: 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).
timeFrame: Each Visit
measure: To compare the safety and tolerability of gefitinib and of docetaxel by Frequency and severity of adverse events (AEs) and laboratory parameters.
timeFrame: Every Visit
Other outcomes:
Locations:
city: In Cheon
country: Korea, Republic of
facility: Research Site
city: Kyonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Asan Medical Center
name: SangWe Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: