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Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00186277
Enrollment
10
Registered
2005-09-16
Start date
2003-12-31
Completion date
2006-12-31
Last updated
2011-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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

DRUGOxaliplatin

Calculated per patient

DRUGTaxotere

Calculated per patient

Sponsors

Sanofi-Synthelabo
CollaboratorINDUSTRY
Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frame
Tolerability of the this combination in patients with recurrent metastatic bladder cancer.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026