Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
* 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 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.
Clareo Health | Docetaxel in Non Small Cell Lung Cancer (NSCLC)
