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

Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: oxaliplatin; Drug: gemcitabine hydrochloride

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract

  • Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1)
• Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2
• At least 1 unidimensionally measurable lesion according to RECIST criteria

• No nonmeasurable lesions only, including any of the following:

  • Ascites
  • Pleural or pericardial effusion
  • Bone metastases
  • Lymphangitis
• No symptomatic cerebral metastases unless they have been stabilized

PATIENT CHARACTERISTICS:

• See Disease Characteristics
• Performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
• Transaminases ≤ 2 times normal (5 times normal if hepatic metastases present)
• Bilirubin ≤ 1.5 times normal
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for at least 6 months after completion of treatment
• No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
• No peripheral neuropathy ≥ grade 2
• No uncontrolled infection

• No other medical conditions that could interfere with evaluating tolerability, including any of the following:

  • Congestive heart failure
  • Angina pectoris that cannot be stabilized with medication
  • Myocardial infarction within the past 12 months
  • Serious thromboembolic disease
• No psychologic, social, or geographic reason that would make follow-up impossible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy for advanced disease
• More than 4 weeks since prior radiotherapy to a target measurable lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gemcitabine,; •Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.	Drug: gemcitabine hydrochloride
Experimental: Gemcitabine, Oxaliplatine; •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.	Drug: oxaliplatin; Drug: gemcitabine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	From baseline to the end of treatment, up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Damien Pouessel, MD, Institut du Cancer de Montpellier - Val d'aurelle

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: February 29, 2008
• First Posted (Estimated): March 3, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Oxaliplatin; Gemcitabine
• Other Study ID Numbers: CDR0000574179; CLCC-VESUNFIT; RECF0368; SANOFI-AVENTIS-CLCC-VESUNFIT; LILLY-CLCC-VESUNFIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No