Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg

Phase II Multi-centre Randomized Controlled Study of Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg

This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Gefitinib 500mg/Gefitinib 250mg

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Cancer Center of Sun-Yat Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
2. received at least one chemotherapy regimen
3. with stable disease after a month treatment of gefitinib(CT scan)
4. the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
5. Age >18 years, either sex
6. with a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
7. WHO performance status(PS)<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)
8. N>=1.5×109/L, Plt>=1.5×109/L,Hb>=10g/dL
9. ALP<2.5×ULN.If ALP>=2.5ULN, AST&ALT should <1.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN，AST&ALT<2.5ULN(without liver metastasis) or <5ULN (with liver metastasis).
10. Signed and dated informed consent before the start of specific protocol procedures.
11. recruiting and receiving treatment in 5 days after last CT scan
12. Patients able to taken oral drug

Exclusion Criteria:

1. Life expectancy <= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
2. experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
3. can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
4. allergic to gefitinib
5. Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
6. Pregnant or breast-feeding women
7. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
8. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Oral Drug gefitinib(Iressa) 500 mg Everyday	Drug: Gefitinib 500mg/Gefitinib 250mg; Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively; Other Names: Iressa
Active Comparator: 2; Oral Drug gefitinib(Iressa) 250 mg Everyday	Drug: Gefitinib 500mg/Gefitinib 250mg; Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively; Other Names: Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparing the difference of Response rate(CR & PR)	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms	3 and a half years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Wu Jieping Medical Foundation

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 8, 2013
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: 08-JC-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No