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
18 Years
N/A
Both
Bladder Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Safety Issue:
No
Principal Investigator
Damien Pouessel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
United States: Federal Government
Study ID:
CDR0000574179
NCT ID:
NCT00627432
Start Date:
July 2004
Completion Date:
Related Keywords:
- Bladder Cancer
- stage III bladder cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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