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

NCT ID: NCT01017679

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral Drug gefitinib(Iressa) 500 mg Everyday

Group Type EXPERIMENTAL

Gefitinib 500mg/Gefitinib 250mg

Intervention Type DRUG

Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively

2

Oral Drug gefitinib(Iressa) 250 mg Everyday

Group Type ACTIVE_COMPARATOR

Gefitinib 500mg/Gefitinib 250mg

Intervention Type DRUG

Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively

Interventions

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Gefitinib 500mg/Gefitinib 250mg

Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively

Intervention Type DRUG

Other Intervention Names

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Iressa

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wu Jieping Medical Foundation

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Profressor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Cancer Center of Sun-Yat Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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08-JC-003

Identifier Type: -

Identifier Source: org_study_id