Oxaliplatin With Gemcitabine in Patients With Carcinoma o... | NCT00127595

Studies
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

NCT00127595

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Terminated

Last Update Posted

Aug 24, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Carcinoma, Transitional Cell

Interventions

gemcitabine, oxaliplatin

Countries

France

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Aug 5, 2005

First Submission Date that Met QC Criteria

Aug 5, 2005

First Posted Date

Aug 8, 2005Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2005

Last Update Posted Date

Aug 24, 2005Estimated

Description Module

Brief Summary

This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine, oxaliplatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)

Secondary Outcomes

Measure	Description	Time Frame
overall survival
disease free survival
toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Transitional cell carcinoma
Histologically-proven
Locally advanced unresectable or metastatic
With at least one measurable target
Informed consent signed

Exclusion Criteria:

Previous chemotherapy
Previous radiotherapy
Performance status >=2
Peripheral neuropathy >=1

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
Christine THEODORE, Dr	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94805	France

Condition Browse Module

MeSH Terms

ID	Term
D002295	Carcinoma, Transitional Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C508870	gemcitabine-oxaliplatin regimen

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided