Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Conditions
Toxicity - Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Objective response rate, Time to Progression, Quality of Live
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gefitinib Type: Drug
Name: Pemetrexed Type: Drug
Name: Cisplatin or carboplatin Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Jianhua Chang, MD,PhD - 13916619284 - changjianhua@hotmail.com
Start Date
December 2009
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page