Back to resultsGemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Suspended
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
Eligibility 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
Sites / Locations
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Outcomes
Primary Outcome Measures
Objective response rate
Secondary Outcome Measures
Tolerability
Overall survival
Progression-free survival
Quality of life as assessed by QLQ-C30 and QLQ-LC13
Duration of response
Full Information
NCT ID
NCT00627432
First Posted
February 29, 2008
Last Updated
October 6, 2010
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT00627432
Brief Title
Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Suspended
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Objective response rate
Secondary Outcome Measure Information:
Title
Tolerability
Title
Overall survival
Title
Progression-free survival
Title
Quality of life as assessed by QLQ-C30 and QLQ-LC13
Title
Duration of response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien Pouessel, MD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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