Urinary Bladder Neoplasms
Conditions
Keywords
Cancer, Neoplasms, Bladder, Urothelial Tract
Brief summary
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
Interventions
administered on day 1 as a 1-hour infusion
DRUGgemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion
DRUGcisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer * ECOG Performance Status 0 or 1 * No prior palliative chemotherapy
Exclusion criteria
* (Neo)Adjuvant chemotherapy if \< 6 months between end of (neo)adjuvant chemotherapy and relapse * Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization * Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose \> 300 mg/m² 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 |
|---|---|
| Overall survival defined as the time interval from the date of randomization to the date of death due to any cause | study period |
Secondary
| Measure | Time frame |
|---|---|
| Radiological tumor assessments (CT/MRI) | at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression |
| Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status | at screening and every cycle |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, France, India, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United States
Outcome results
None listed