Know Cancer

or
forgot password

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)


Phase 3
18 Years
N/A
Not Enrolling
Both
NSCLC

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Survival

Safety Issue:

No

Principal Investigator

SangWe Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

D7913L00039

NCT ID:

NCT00478049

Start Date:

September 2005

Completion Date:

February 2009

Related Keywords:

  • NSCLC
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung

Name

Location