Status:
COMPLETED
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Efficacy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than ...
Eligibility Criteria
Inclusion
- Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
- With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
- with an Eastern CooperativeOncology Group performance status of 0 or 1,
- At least 18 years of age
- adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
- Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
- patients had fully recovered from its acute effects.
Exclusion
- peripheral neuropathy \> National Cancer Institute Common Toxicity Criteria grade 1
- progressive brain metastases,
- uncontrolled third-space fluid retention before study entry.
- Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01194453
Start Date
November 1 2009
End Date
August 1 2012
Last Update
June 16 2016
Active Locations (1)
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1
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China