Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-04-30

Brief Summary

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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

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Conditions

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Carcinoma, Transitional Cell

Keywords

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carcinoma of the urothelial tract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemcitabine, oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Christine THEODORE, Dr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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GEMOX

Identifier Type: -

Identifier Source: org_study_id