A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- Irinotecan
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Hellenic Oncology Research Group
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Overall Response Rate
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
IC
Intervention: Irinotecan
1
IC
Intervention: Cisplatin
2
PC
Intervention: Cisplatin
2
PC
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary Outcomes
- 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)