Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00127595
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Duration (Months): 39
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Carcinoma, Transitional Cell	Drug: gemcitabine, oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Jan 1, 2002
• Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. overall survival []

2. disease free survival []

3. toxicity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00127595
• Other Study ID Numbers: GEMOX
• First Posted: Aug 8, 2005
• Last Update Posted: Aug 24, 2005
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: carcinoma of the urothelial tract
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Gemcitabine; Oxaliplatin

Study Results

No Results Posted as of Aug 24, 2005