Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

This study has been terminated.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
First received: August 5, 2005
Last updated: August 23, 2005
Last verified: August 2005

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.

Condition Intervention Phase
Carcinoma, Transitional Cell
Drug: gemcitabine, oxaliplatin
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)

Secondary Outcome Measures:
  • overall survival
  • disease free survival
  • toxicity

Estimated Enrollment: 28
Study Start Date: January 2002
Estimated Study Completion Date: April 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127595

Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Christine THEODORE, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127595     History of Changes
Other Study ID Numbers: GEMOX
Study First Received: August 5, 2005
Last Updated: August 23, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
carcinoma of the urothelial tract

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 22, 2014