Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Not Recruiting

Trial ID: NCT00186277

Purpose

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

Official Title

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

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

Intervention(s):

drug: Oxaliplatin

drug: Taxotere

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305