Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Sanofi-Synthelabo
• Treatments: Docetaxel; Oxaliplatin

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