Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186277
• Collaborator: Sanofi-Synthelabo (Industry)
• Enrollment: 10
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• 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: Dec 1, 2003
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. Tolerability of the this combination in patients with recurrent metastatic bladder cancer. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186277
• Other Study ID Numbers: BLDR0001; BLDR0001
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 30, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Docetaxel; Oxaliplatin

Study Results

No Results Posted as of Mar 30, 2011