Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 337
- Locations
- 160
- Primary Endpoint
- Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1
Intervention: larotaxel (XRP9881) (Drug)
1
Intervention: cisplatin (Drug)
2
Intervention: gemcitabine (Drug)
2
Intervention: cisplatin (Drug)
Outcomes
Primary Outcomes
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Time Frame: study period
Secondary Outcomes
- 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)