First-Line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker - Full Text View

Sponsors and Collaborators:	National Cancer Center, Korea AstraZeneca
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00455936

Purpose

The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as compared with the standard combination chemotherapy.

This is a randomized, open label, parallel group, phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung.

After stratification by gender, performance status, and disease stage, patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression, unacceptable toxicity or patient's refusal, whichever is sooner. The chemotherapy will be administered for no more than nine cycles.

Condition	Intervention	Phase
Lung Cancer	Drug: Gefitinib Procedure: chemotherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase III Study of Gefitinib (IRESSATM) Versus Standard Chemotherapy (Gemcitabine Plus Cisplatin) as First-Line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride ZD1839

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

To examine whether gefitinib monotherapy would improve overall survival of never-smokers with adenocarcinoma of lung as compared with standard chemotherapy [ Time Frame: from the date of randomization to the date of death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare disease control rate (SD+PR+CR) [ Time Frame: from the date of randomization to the date of death from any cause the result of each should be recorded separately ] [ Designated as safety issue: No ]
To compare Progression-Free survival [ Time Frame: from the date of randomization to the first date of progression of disease or of death from any cause ] [ Designated as safety issue: No ]
To compare the quality of life [ Time Frame: D1 of each cycle during treatment period ] [ Designated as safety issue: No ]
To compare safety profile [ Time Frame: From randomization up to and including the 30 day follow-up period ] [ Designated as safety issue: Yes ]
To collect the tissue samples for the study of predictors of gefitinib (optional) [ Time Frame: screening period ] [ Designated as safety issue: No ]
To compare the objective response rate (CR+PR) [ Time Frame: from the date of randomization to the date of death from any cause the result of each should be recorded separately ] [ Designated as safety issue: No ]

Enrollment:	315
Study Start Date:	October 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Gefitinib 250mg table/QD, daily every 3 weeks	Drug: Gefitinib gefitinib 250mg tablet/ QD daily until Progression
B: Active Comparator gemcitabine 1250mg/m2 iv on D1 & D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks	Procedure: chemotherapy gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles

Detailed Description:

Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks

standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3 week cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or without BAC features; however, adenocarcinoma combined with other histology, such as small cell carcinoma or squamous carcinoma, is not allowed.
Stage IIIB with malignant pleural effusion/pleural seeding or stage IV patients
Age 18-75
Never-smoking defined as not more than 100 cigarettes during the lifetime
ECOG performance status of 0-2
No prior invasive malignancies 5 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
Serum creatinine ≤ 1.5 mg/dL, serum bilirubin ≤ 1.2 mg/dL (1 x UNL) and SGOT/SGPT ≤ 100 IU/L (2.5 x UNL)
Serum Hgb ≥ 10 gm/dl, platelet count ≥ 100,000/ul, total WBC count >= 4,000/uL, absolute neutrophil count ≥ 1,500/ul
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. The only approved consent form is attached to this protocol
The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids

Exclusion Criteria:

Pregnancy or breast-feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Major surgery other than biopsy within the past two week.
Known severe hypersensitivity to Gefitinib or any of the excipients of this product
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455936

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea, Republic of, Gyenggi-do
National Cancer Center, Korea
Goyang-si, Gyenggi-do, Korea, Republic of, 411-769

Sponsors and Collaborators

National Cancer Center, Korea

AstraZeneca

Investigators

Study Chair:

Jin Soo Lee, M.D.

National Cancer Center, Korea

More Information

No publications provided

Responsible Party:	National Cancer Center, Korea ( Jin Soo Lee )
Study ID Numbers:	NCCCTS-05-126, D7913L00054
Study First Received:	April 3, 2007
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00455936 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:

Adenocarcinoma
NSCLC
gemcitabine

Cisplatin
Gefitinib
Never smoker

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases

Cisplatin
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Gemcitabine
Gefitinib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Gefitinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009