Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186277
• Other study ID #: BLDR0001
• Secondary ID: BLDR0001
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 28, 2011
• Start date: December 2003
• Est. completion date: December 2006

Study information

• Verified date: March 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Oxaliplatin
Calculated per patient
• Taxotere
Calculated per patient

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of the this combination in patients with recurrent metastatic bladder cancer.		1 year	No