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

This study has been completed.
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01017679
First received: November 10, 2009
Last updated: December 8, 2013
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Gefitinib 500mg/Gefitinib 250mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Comparing the difference of Response rate(CR & PR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms [ Time Frame: 3 and a half years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: May 2009
Study Completion Date: December 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Iressa

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017679

Locations
China, Guangdong
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Wu Jieping Medical Foundation
Investigators
Principal Investigator: Li Zhang, MD Cancer Center of Sun-Yat Sen University
  More Information

No publications provided

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01017679     History of Changes
Other Study ID Numbers: 08-JC-003
Study First Received: November 10, 2009
Last Updated: December 8, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014