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Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127595
First Posted: August 8, 2005
Last Update Posted: August 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127595


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

ClinicalTrials.gov Identifier: NCT00127595     History of Changes
Other Study ID Numbers: GEMOX
First Submitted: August 5, 2005
First Posted: August 8, 2005
Last Update Posted: August 24, 2005
Last Verified: August 2005

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

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