Status:
TERMINATED
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sanofi
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00263016
Start Date
May 1 2005
Last Update
March 20 2008
Active Locations (1)
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1
Sanofi-aventis
Hong Kong, Hong Kong