Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in F... | NCT00625664

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

NCT00625664

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 5, 2016Estimated

Enrollment

337Actual

Phase

Phase 3

Conditions

Urinary Bladder Neoplasms

Interventions

larotaxel (XRP9881)
gemcitabine
cisplatin

Countries

United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
France
India
Israel
Italy
Mexico
Netherlands
Poland
Russia
South Africa
Spain
Sweden
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
EUDRACT: 2007-001943-23

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 6, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 6, 2016

Certification/Extension First Posted Date

May 5, 2016Estimated

Last Update Submitted Date

Apr 6, 2016

Last Update Posted Date

May 5, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

337Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: larotaxel (XRP9881) Drug: cisplatin
2	Active Comparator		Drug: gemcitabine Drug: cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
larotaxel (XRP9881)	Drug	administered on day 1 as a 1-hour infusion	1

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Investigational Site Number 840068		Anchorage	Alaska	99508	United States
Sanofi-Aventis Investigational Site Number 840035

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds