Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00614965
- Lead Sponsor
- Hellenic Oncology Research Group
- 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 proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Irinotecan IC 1 Cisplatin IC 2 Pemetrexed PC 2 Cisplatin PC
- Primary Outcome Measures
Name Time Method Overall Response Rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
- Secondary Outcome Measures
Name Time Method Time to Tumor Progression 1-year Overall Survival 1-year Toxicity profile between the two treatment arms Toxicity assessment on each chemotherapy cycles Quality of life assessment Assessment every two cycles
Trial Locations
- Locations (2)
Air Forces Military Hospital, Dep of Medical Oncology
🇬🇷Athens, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece