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)
18 Years
75 Years
Both
Non Small Cell Lung Cancer
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate
Outcome Time Frame:
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Safety Issue:
No
Principal Investigator
Sofia Aggelaki, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete, Dep of Medical Oncology
Authority:
Greece: National Organization of Medicines
Study ID:
CT/06.16
NCT ID:
NCT00614965
Start Date:
November 2006
Completion Date:
March 2010
Related Keywords:
- Non Small Cell Lung Cancer
- Cancer
- NSCLC
- second-line chemotherapy
- irinotecan
- pemetrexed
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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