Trial | NCT01017679  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gefitinib ...

  • Study Participants

    96
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 Started
May 31
2009
Primary Completion
Jan 31
2012
Study Completion
Dec 31
2013
Last Update
Dec 10
2013
Estimate

Drug Gefitinib 500mg/Gefitinib 250mg

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

  • Other names: Iressa

1 Experimental

Oral Drug gefitinib(Iressa) 500 mg Everyday

2 Active Comparator

Oral Drug gefitinib(Iressa) 250 mg Everyday

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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.
No Results Posted