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Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Bladder Cancer

Thank you

Trial Information

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

To test the combination of oxaliplatin chemotherapy in combination with taxotere
chemotherapy in patients with advanced bladder cancer who have failed one prior

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

Type of Study:


Study Design:

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

Outcome Measure:

Tolerability of the this combination in patients with recurrent metastatic bladder cancer.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

December 2006

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms



Stanford University School of MedicineStanford, California  94305-5317