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

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer

Toxicity

Treatments

Drug: Gefitinib

Drug: Cisplatin or carboplatin

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT01192243

Iressa combined with Pem/Cis

Details and patient eligibility

About

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).

Enrollment

68 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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