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

NCT00627432 | Completed Phase 2

• 5 other identifiers: CDR0000574179CLCC-VESUNFITRECF0368SANOFI-AVENTIS-CLCC-VESUNFITLILLY-CLCC-VESUNFIT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  From baseline to the end of treatment, up to 6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Gemcitabine,

ACTIVE COMPARATOR

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

Drug: gemcitabine hydrochloride

Gemcitabine, Oxaliplatine

EXPERIMENTAL

•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: gemcitabine hydrochloride; Drug: oxaliplatin

Interventions

gemcitabine hydrochloride DRUG

Gemcitabine,; Gemcitabine, Oxaliplatine

oxaliplatin DRUG

Gemcitabine, Oxaliplatine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

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

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Damien Pouessel, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 3, 2008
• Study Start: July 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

FR (1)