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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Transitional Cell

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Christine THEODORE, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GEMOX

NCT ID:

NCT00127595

Start Date:

January 2002

Completion Date:

April 2005

Related Keywords:

  • Carcinoma, Transitional Cell
  • carcinoma of the urothelial tract
  • Carcinoma
  • Carcinoma, Transitional Cell

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