ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Conditions
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
PFS
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ABX Combined With Cisplatin Type: Drug
Name: Gemcitabine Combined With Cisplatin Type: Drug
Overall Status
Recruiting
Summary
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 1.18~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.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) 7.Signed written informed consent

Exclusion Criteria:

- Patients have 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: Chang jian hua, MD,PHD - 64175590 - changjianhua@163.com
Start Date
December 2011
Completion Date
December 2013
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page