Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192243
• Other study ID #: Iressa combined with Pem/Cis
• Status: Recruiting
• Phase: Phase 2
• First received: August 4, 2010
• Last updated: September 2, 2010
• Start date: December 2009

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: Jianhua chang, MD,PHD
• Phone: 13916619284
• Email: changjianhua[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer

• Age from 18 to 70 years old

• At least one target lesion diameter spiral CT = 1 cm, or the common CT = 2 cm, and can be measured by imaging tools

• ECOG 0-1

• Expected life time longer than 12 weeks

• Normal laboratory values:

leucocyte= 4×109/L neutrophil= 1.5×109/L platelet=100×109/L Hemoglobin= 10g/L ALT and AST =2.5×ULN (=5×ULN if liver metastasis)

Exclusion Criteria:

• Patients have not used drugs according to protocol

• Patients were allergic to pemetrexed or cisplatin

• Patients received radiotherapy or other biological treatment 4 weeks before the trial

• Uncontrolled hydrothorax or hydropericardium

• neuropathy toxicity = CTC 3

• Severe symptomatic heart disease

• Active upper gastrointestinal ulcer or digestive disfunction

• Severe infection or metabolic disfunction

• Patients with other malignant tumor

• Uncontrolled brain metastases

• Patients have accepted other clinical trials

• Female patients during their pregnant and lactation period, or patients without contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• Toxicity

Intervention

Drug:
• Gefitinib
250mg qd po d3-16
• Pemetrexed
500mg/m2 venous infusion,D1,q3w
• Cisplatin or carboplatin
Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		six weeks	Yes
Secondary	Number of Participants with Adverse Events	according to NCI CTC V3.0	six weeks	Yes
Secondary	Progression free survival		six weeks	No
Secondary	quality of life	according to FACT-LCS scores	six weeks	Yes