Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127595

Enrollment

Registered

2005-08-08

Start date

2002-01-31

Completion date

2005-04-30

Last updated

2005-08-24

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

Conditions

Carcinoma, Transitional Cell

Keywords

carcinoma of the urothelial tract

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.

Interventions

DRUGgemcitabine, oxaliplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
overall survival	—
disease free survival	—
toxicity	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026