Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Gustave Roussy

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Transitional Cell

Treatments: Drug: gemcitabine, oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00127595

GEMOX

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)