Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Stanford University

Status and phase

Completed

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: Taxotere

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00186277

BLDR0001 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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