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Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Taxotere
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

Tolerability of the this combination in patients with recurrent metastatic bladder cancer.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 28, 2011
Sponsor
Stanford University
Collaborators
Sanofi-Synthelabo
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1. Study Identification

Unique Protocol Identification Number
NCT00186277
Brief Title
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Official Title
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
Sanofi-Synthelabo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Calculated per patient
Intervention Type
Drug
Intervention Name(s)
Taxotere
Other Intervention Name(s)
Docetaxel
Intervention Description
Calculated per patient
Primary Outcome Measure Information:
Title
Tolerability of the this combination in patients with recurrent metastatic bladder cancer.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sandy Srinivas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

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