Overview

Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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 progression. - To evaluate the safety profile.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Carboplatin
Docetaxel
Gemcitabine
Criteria
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.