Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Phase 2

Suspended

• Conditions: Bladder Cancer

• Registration Number: NCT00627432
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.

Secondary

* Determine the tolerance of these regimens in these patients.

* Determine the overall survival and progression-free survival of patients treated with these regimens.

* Determine the quality of life of patients treated with these regimens.

* Determine the duration of response in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.

* Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.

Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Primary Completion: 2009-03
• Status Verified: 2009-07
• Last Update Submitted: 2010-10-06
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate

Secondary Outcome Measures

Name	Time	Method
Tolerability
Overall survival
Progression-free survival
Quality of life as assessed by QLQ-C30 and QLQ-LC13
Duration of response

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France