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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00627432
First received: February 29, 2008
Last updated: October 6, 2010
Last verified: July 2009
  Purpose

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 Intervention Phase
Bladder Cancer
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Quality of life as assessed by QLQ-C30 and QLQ-LC13 [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2004
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627432

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Study Chair: Damien Pouessel, MD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00627432     History of Changes
Other Study ID Numbers: CDR0000574179, CLCC-VESUNFIT, RECF0368, SANOFI-AVENTIS-CLCC-VESUNFIT, LILLY-CLCC-VESUNFIT
Study First Received: February 29, 2008
Last Updated: October 6, 2010
Health Authority: United States: Federal Government

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 16, 2014