First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00455936
First received: April 3, 2007
Last updated: October 22, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • overall survival [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare Progression-Free survival [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]
  • To compare the quality of life [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • To compare safety profile [ Time Frame: every 9 weeks ] [ 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
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study arm
Gefitinib 250mg table/QD, daily every 3 weeks
Drug: Gefitinib
gefitinib 250mg tablet/ QD daily until Progression
Other Name: Treamtment Arm
Active Comparator: control arm
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
Other Name: standard chemotherapy arm

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:

  1. 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.
  2. Stage IIIB with malignant pleural effusion/pleural seeding or stage IV patients
  3. Age 18-75
  4. Never-smoking defined as not more than 100 cigarettes during the lifetime
  5. ECOG performance status of 0-2
  6. No prior invasive malignancies 5 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
  7. 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)
  8. Serum Hgb ≥ 10 gm/dl, platelet count ≥ 100,000/ul, total WBC count >= 4,000/uL, absolute neutrophil count ≥ 1,500/ul
  9. 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
  10. 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:

  1. Pregnancy or breast-feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
  2. Major surgery other than biopsy within the past two week.
  3. Known severe hypersensitivity to Gefitinib or any of the excipients of this product
  4. Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  5. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  6. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  7. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
  8. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Soo Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00455936     History of Changes
Other Study ID Numbers: NCCCTS-05-126, D7913L00054
Study First Received: April 3, 2007
Last Updated: October 22, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
Adenocarcinoma
NSCLC
gemcitabine
Cisplatin
Gefitinib
Never smoker

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014