Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
Primary Objective: * To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3 courses of docetaxel/cisplatin. Secondary Objectives : * To compare the time to progression after chemotherapy treatment between the IC and DC arms of treatment. * To compare the toxicity profile of the IC and DC arms of treatment.
Interventions
DRUGDocetaxel
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven non-small cell lung carcinoma at first diagnosis. * Stage IIIB or IV disease. * Tumour considered unresectable. * Performance status Karnofsky index \> 60% or WHO performance status \< or = 1. * Previous therapy * Chemotherapy: None. * Previous radiation therapy: prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal. * Laboratory requirements: * Hematology: * Neutrophils ≥ 2.0 10\^9/l, * Platelets ≥ 100 10\^9/l, * Hemoglobin ≥ 10 g/dl. * Hepatic function:Total bilirubin \< 1 Upper Normal Limit (UNL), AST (SGOT) and ALT (SGPT) \< 2.5 UNL,Alkaline phosphatase \< 5 UNL ; except in presence of only bone metastasis and in absence of any liver disorders. Patients with AST and/or ALT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL are not eligible for the study. * Renal function: Creatinine \< 140 µmol/l (1.6 mg/dl) ; if limit values, the calculated creatinine clearance should be \> 60 ml/min.
Exclusion criteria
* Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation. * Known clinical brain or leptomeningeal involvement. * Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by National Cancer Institute criteria. * Other serious illness or medical condition: * Congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias. * History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. * Active uncontrolled infection. * Peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids. * Past or current history of neoplasm other than non-small cell lung cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix. * Concurrent treatment with prednisone (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or unless chronic treatment (initiated \> 6 months prior to study entry) at low dose (\< 20 mg methylprednisolone or equivalent). * Definite contraindications for the use of corticosteroids. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry. * Concurrent treatment with any other anti-cancer therapy. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumour response rate | — |
| Survival at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Countries
Hong Kong
Outcome results
None listed