Iressa as Second Line Therapy in Advanced NSCLC-Asia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00478049

Purpose

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	Intervention	Phase
NSCLC	Drug: Gefitinib Drug: Docetaxel	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors [ Time Frame: Survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	163
Study Start Date:	September 2005
Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Active Comparator Docetaxel	Drug: Docetaxel intravenous infusion
2: Experimental Gefitinib	Drug: Gefitinib 250 mg oral tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478049

Locations

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

AstraZeneca

Investigators

Principal Investigator:

SangWe Kim, MD

Asan Medical Center

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D7913L00039
Study First Received:	May 23, 2007
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00478049 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Non-Small Cell Lung Cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Protein Kinase Inhibitors
Gefitinib
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Docetaxel

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009