Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer (CILAB)

Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILAB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000036

Enrollment

900

Registered

2008-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bladder Cancer Health Condition 2: N328- Other specified disorders of bladder

Interventions

Intervention1: Larotaxel+Cisplatin: Larotaxel 50 mg/mÂ² IV over 1h on day 1 Cisplatin75 mg/mÂ² Control Intervention1: Gemcitabine+Cisplatin: Gemcitabine 1000mg/m&sup2

on Day 1, 8, and 15 administered as a 30minute infusion

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer 2.ECOG Performance Status ≤ 2 3.No prior palliative chemotherapy

Exclusion criteria

Exclusion criteria: 1. (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse 2.Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization 3.Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²

Design outcomes

Primary

Measure	Time frame
To compare overall survival (OS) of patients administered larotaxel in combination with cisplatin vs. gemcitabine in combination with cisplatin for the treatment of locally advanced /metastatic urothelial tract or bladder cancer Timepoint: The primary efficacy endpoint is the Overall Survival (OS) that is defined as the time from the date of randomization to death with all cause.	—

Secondary

Measure	Time frame
To compare Progression Free Survival (PFS), Objective Response Rate (ORR), time to definitive deterioration of PS, Duration of Response (DR), and time to definitive 5% weight loss of larotaxel in combination with cisplatin vs. gemcitabine combined with cisplatin. To assess the safety and tolerability of larotaxel in combination with cisplatin and gemcitabine with cisplatin Timepoint: Secondary efficacy endpoints are PFS, ORR, time to infinitive deterioration of PS, DR, and time to definitive 5% weight loss.	—

Measure

Time frame

To compare Progression Free Survival (PFS), Objective Response Rate (ORR), time to definitive deterioration of PS, Duration of Response (DR), and time to definitive 5% weight loss of larotaxel in combination with cisplatin vs. gemcitabine combined with cisplatin. To assess the safety and tolerability of larotaxel in combination with cisplatin and gemcitabine with cisplatin Timepoint: Secondary efficacy endpoints are PFS, ORR, time to infinitive deterioration of PS, DR, and time to definitive 5% weight loss.

—

Countries

France, India, Poland, Romania, Russian Federation, United States of America

Contacts

Public ContactGayatri Jaiswal

Sanofi Synthelabo India Limited

Gayatri.jaiswal@sanofi-aventis.com02230707806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026