Status:
COMPLETED
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sanofi
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: * To classify the 2 study groups, according to the tumoral response. Secondary objectives: * To evaluate the percentage of focused control per year. * To calculate the time until...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Non small cell lung cancer confirmed by histology or by cytology.
- IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
- General stage 0-1 at the ECOG scale
- Loss of weight less than 5% in the 3 previous months from diagnose.
- Pulmonary function and gasometry results: FEV1 \> 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) \> 30%, PCO2 \< 45 mmHg and PO2 \> 60 mmHg.
- Normal medullar function (hemoglobin \> 11 g/dl, total WBC \> 1,5 x 10\^9/l, platelets \> 100 x 10\^9/l)
- Appropriate renal and hepatic functions
- CTScan
- Anticonceptive method
- Available laboratory test (maximum 1 month before)
- Exclusion criteria:
- Pleural discharge, upper cava vein syndrome or supraclavicular affectation.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00258739
Start Date
October 1 2001
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Barcelona, Spain