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

Phase 2

Completed

• Conditions: Bladder Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: oxaliplatin

• 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.

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
• Study Completion: 2009-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine,	gemcitabine hydrochloride	•Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
Gemcitabine, Oxaliplatine	gemcitabine hydrochloride	•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.
Gemcitabine, Oxaliplatine	oxaliplatin	•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.

Primary Outcome Measures

Name	Time	Method
Objective response rate	From baseline to the end of treatment, up to 6 months

Secondary Outcome Measures

Name	Time	Method
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE)	From baseline to the end of treatment, up to 6 months
Overall survival	From baseline to the end of treatment, up to 6 months
Progression-free survival	From baseline to the end of treatment, up to 6 months
Quality of life as assessed by QLQ-C30 and QLQ-LC13	From baseline to the end of treatment, up to 6 months
Duration of response	From baseline to the end of treatment, up to 6 months

Trial Locations

Locations (1)

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