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Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00186277
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 30, 2011
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by:
Stanford University

Study Description
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Brief Summary:
To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Oxaliplatin Drug: Taxotere Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Study Start Date : December 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Intervention Details:
  • Drug: Oxaliplatin
    Calculated per patient
    Other Name: Eloxatin
  • Drug: Taxotere
    Calculated per patient
    Other Name: Docetaxel

Outcome Measures
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Primary Outcome Measures :
  1. Tolerability of the this combination in patients with recurrent metastatic bladder cancer. [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186277


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Sanofi-Synthelabo
Investigators
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Principal Investigator: Dr. Sandy Srinivas Stanford University
More Information
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Responsible Party: Sandy Srinivas, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186277    
Other Study ID Numbers: BLDR0001
BLDR0001 ( Other Identifier: Stanford University )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
 Docetaxel
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action