Bladder Cancer
Conditions
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.
Interventions
Calculated per patient
Calculated per patient
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability of the this combination in patients with recurrent metastatic bladder cancer. | 1 year |
Countries
United States