Status:
COMPLETED
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Lead Sponsor:
Fudan University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01810367
Start Date
December 1 2011
End Date
December 1 2015
Last Update
February 23 2016
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032