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Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Primary Purpose

Carcinoma, Transitional Cell

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

gemcitabine, oxaliplatin

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell focused on measuring carcinoma of the urothelial tract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Gustave Roussy

Outcomes

Primary Outcome Measures

response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)

Secondary Outcome Measures

overall survival

disease free survival

toxicity

Full Information

NCT ID

NCT00127595

First Posted

August 5, 2005

Last Updated

August 23, 2005

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00127595

Brief Title

Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Official Title

A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Terminated

Study Start Date

January 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Transitional Cell

Keywords

carcinoma of the urothelial tract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

gemcitabine, oxaliplatin

Primary Outcome Measure Information:

Title

response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)

Secondary Outcome Measure Information:

Title

overall survival

Title

disease free survival

Title

toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine THEODORE, Dr

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

12. IPD Sharing Statement

Learn more about this trial

Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

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