Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
NCT ID: NCT00186277
Last Updated: 2011-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2003-12-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Oxaliplatin
Calculated per patient
Taxotere
Calculated per patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Sanofi-Synthelabo
INDUSTRY
Stanford University
OTHER
Responsible Party
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Stanford University School of Medicine
Principal Investigators
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Dr. Sandy Srinivas
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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Other Identifiers
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BLDR0001
Identifier Type: OTHER
Identifier Source: secondary_id
BLDR0001
Identifier Type: -
Identifier Source: org_study_id
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