Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186277
First received: September 13, 2005
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.


Condition Intervention Phase
Bladder Cancer
Drug: Oxaliplatin
Drug: Taxotere
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tolerability of the this combination in patients with recurrent metastatic bladder cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxaliplatin
    Calculated per patient
    Other Name: Eloxatin
    Drug: Taxotere
    Calculated per patient
    Other Name: Docetaxel
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186277

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Sanofi-Synthelabo
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186277     History of Changes
Other Study ID Numbers: BLDR0001, BLDR0001
Study First Received: September 13, 2005
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014