Docetaxel in Non Small Cell Lung Cancer (NSCLC)

A Phase II Pilot Study of Combination of Irinotecan and Cisplatin in Docetaxel/Cisplatin-Responsive Advanced Non-Small Cell Lung Cancer

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.

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.