None listed
Conditions
Interventions
treatment group 1 Type of group
Docetaxel will be administered as an infusion for 1 hour, followed by cisplatin, administered as an infusion for 1 to 3 hours, followed by 5-FU administered as a 24-hour continuous infusion for 5 consecutive days.
Group name:treatment group 2 Type of group
On Day 1 of the treatment cycle you will receive cisplatin, administered as an infusion for 1 to 3 hours, followed by 5-FU, administered as a 24-hour continuous infusion, for 5 consecutive days. This treatment will be repeated every 4 weeks. Four weeks are equivalent to one cycle of treatment
for this treatment group.
Sponsors
AVENTIS PHARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Total bilirubin <1 x ULN, AST (SGOT) and ALT (SGPT) <2.5 x UNL, alkaline phosphatase <5 xUNL
Exclusion criteria
Exclusion criteria: not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Efficacy will be evaluated by determining the time to progression and survival in each arm of Phase III. Patients will be evaluated for tumor response every 8 weeks and will be considered as evaluable for tumor response after receiving minus 2-3 treatment cycles of the study. Measure:Statistically significant increase in time to progression (TTP) for the test arm (TXr + CDDP + 5-FU) in relation to the control arm (CDDP + 5-FU). Timepoints:8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety will be assessed the safety profile of the treatment arms The clinical and laboratory symptoms will be graded according to the common NCIC-CTG toxicity criteria. Measure:The secondary objective is to evaluate the qualitative and quantitative safety profile of the two test groups Timepoints:8 keeks | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Colombia, Italy, Mexico, Peru, Portugal, Russian Federation, Slovakia, Spain, Taiwan, United States
Outcome results
None listed