Status:
COMPLETED
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.
Detailed Description
To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.
Eligibility Criteria
Inclusion
- Patient Population Type: Advanced Muscle Invasive Bladder Cancer
- Prior Therapy: One prior therapy for advanced disease
- Disease: Measurable disease
- ECOG Performance: 0,1
- Indication: Histologically Proven Carcinoma of the bladder
- For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
- Allergies: No known allergy to one of the study drugs
- Patient Status:
- No CNS metastases
- No peripheral neuropathy \> grade1
- No other serious concomitant illness
- Fully recovered from any prior therapy
- Informed Consent: Patient and doctor have signed informed consent
- Lower Age Limit: Lower age limit \>18
- Upper Age Limit: Upper Age Limit \<70
- ANC: ANC \>1500/mm3 or WBC \> 3000/mm3
- Platelets: Platelets \>100,000/mm3
- Creatinine: Creatinine \<1.8mg/dL
- Bilirubin: Bilirubin \<=2.0 x ULN
- SGPT: SGPT (ALT) \<=1.5 x ULN (\<4xULN if liver metastases present)
- RBC: Hemoglobin \> 9.0g/dL
- Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
- Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
- No prior exposure to Oxaliplatin
- No cytotoxics or radiation 4 weeks prior to enrolling on protocol
- PT/PTT normal
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00186277
Start Date
December 1 2003
End Date
December 1 2006
Last Update
March 30 2011
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305