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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455936
• Other study ID #: NCCCTS-05-126
• Secondary ID: D7913L00054
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2007
• Last updated: October 22, 2010
• Start date: October 2005
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Cancer

Intervention

Drug:
• Gefitinib
gefitinib 250mg tablet/ QD daily until Progression

Procedure:
• chemotherapy
gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyenggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		every 12 weeks	No
Secondary	To compare Progression-Free survival		every 9 weeks	No
Secondary	To compare the quality of life		every 3 weeks	No
Secondary	To compare safety profile		every 9 weeks	Yes
Secondary	To collect the tissue samples for the study of predictors of gefitinib (optional)		screening period	No
Secondary	To compare the objective response rate (CR+PR)		from the date of randomization to the date of death from any cause the result of each should be recorded separately	No