Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 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 by Histologic Type
Neoplasms, Glandular and Epithelial
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on February 27, 2015