A Phase II Pilot Study of Combination of Irinotecan and Cisplatin in Docetaxel/Cisplatin-Responsive Advanced Non-Small Cell Lung Cancer
- Histologically or cytologically proven non-small cell lung carcinoma at first
- 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:
- 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.
- 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
- 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.