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

NCT ID: NCT00627432

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2009-03-31

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine,

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

Group Type: ACTIVE_COMPARATOR

gemcitabine hydrochloride

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien Pouessel, MD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Countries

France

Other Identifiers

CLCC-VESUNFIT

Identifier Type: -

Identifier Source: secondary_id

RECF0368

Identifier Type: -

Identifier Source: secondary_id

SANOFI-AVENTIS-CLCC-VESUNFIT

Identifier Type: -

Identifier Source: secondary_id

LILLY-CLCC-VESUNFIT

Identifier Type: -

Identifier Source: secondary_id

CDR0000574179

Identifier Type: -

Identifier Source: org_study_id