Status:
COMPLETED
Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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. Giv...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00627432
Start Date
July 1 2004
End Date
March 1 2009
Last Update
February 18 2025
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298