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

NCT01017679 | Completed Phase 2

• 1 other identifier: 08-JC-003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Comparing the difference of Response rate(CR & PR)

  3 years

Secondary Outcomes (1)

• Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms

  3 and a half years

Study Arms (2)

1

EXPERIMENTAL

Oral Drug gefitinib(Iressa) 500 mg Everyday

Drug: Gefitinib 500mg/Gefitinib 250mg

2

ACTIVE COMPARATOR

Oral Drug gefitinib(Iressa) 250 mg Everyday

Drug: Gefitinib 500mg/Gefitinib 250mg

Interventions

Gefitinib 500mg/Gefitinib 250mg DRUG

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

Also known as: Iressa

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
• received at least one chemotherapy regimen
• with stable disease after a month treatment of gefitinib(CT scan)
• the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
• Age \>18 years, either sex
• with a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) at least according to RECIST Criteria
• WHO performance status(PS)\<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)
• N\>=1.5×109/L, Plt\>=1.5×109/L,Hb\>=10g/dL
• 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).
• Signed and dated informed consent before the start of specific protocol procedures.
• recruiting and receiving treatment in 5 days after last CT scan
• Patients able to taken oral drug

You may not qualify if:

• Life expectancy \<= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
• experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
• can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
• allergic to gefitinib
• Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
• Pregnant or breast-feeding women
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Wu Jieping Medical Foundation: collaborator

Study Sites (1)

Cancer Center of Sun-Yat Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profressor

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 20, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2012-01

Locations

CN (1)