Metastatic Prostate Cancer
Conditions
Keywords
Metastatic Androgen Independent Prostate Cancer (MAIPC)
Brief summary
A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.
Interventions
DRUGDocetaxel
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed MAIPC * Documented progressive disease in bone, soft tissue or PSA despite castrate levels of testosterone * If LHRH agonist were used previously it must be kept * Previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida * Previous DES should be held for at least 4 weeks before partcipating in the trial * Chemotherapy naive patients * No prior radioisotope * Less than 25% of bone marrow should be irradiated for prior palliative radiotherapy * KPS\> 70% * Adequate hematologic, hepatic and renal function
Exclusion criteria
* Patients with serious medical illness * History of significant active cardiac disease * History of gastrointestinal ulceration, bleeding or perforation * History of myocardial infarctin within past 12 months * Allergy to sulfonamides or to celecoxib or history of urticaria to any NSAID The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of docetaxel and celecoxib by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart | two consecutive evaluations at least 4 weeks apart |
Secondary
| Measure | Time frame |
|---|---|
| Response in measurable disease by response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0. | response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0. |
Countries
Brazil
Outcome results
None listed