Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Camptothecin; Cisplatin; Irinotecan; Pemetrexed

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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