Status:
COMPLETED
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
Detailed Description
Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been prov...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC
- Age 18 -75 years
- Performance status (WHO) \<2
- Patients progressing after first-line docetaxel/gemcitabine treatment
- Adequate bone marrow (absolute neutrophil count \>1000/mm3, platelet count \>100000/mm3, hemoglobin \> 9 gr/ mm3)
- Adequate liver (bilirubin \<1.5 times upper limit of normal), renal (Creatinine clearance \> 50mg/min) and cardiac (LVEF \>50%) function
- Presence of measurable disease (according to RESIST criteria)
- Informed consent
Exclusion
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00614965
Start Date
November 1 2006
End Date
March 1 2010
Last Update
May 23 2011
Active Locations (2)
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1
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
2
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece