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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627432
Recruitment Status : Suspended
First Posted : March 3, 2008
Last Update Posted : October 7, 2010
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 2

Detailed Description:



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


  • 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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Estimated Primary Completion Date : March 2009

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Tolerability
  2. Overall survival
  3. Progression-free survival
  4. Quality of life as assessed by QLQ-C30 and QLQ-LC13
  5. Duration of response

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627432

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Study Chair: Damien Pouessel, MD Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT00627432     History of Changes
Other Study ID Numbers: CDR0000574179
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs