Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer - Full Text View

Sponsors and Collaborators:	Stanford University Sanofi-Synthelabo
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186277

Purpose

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

Condition	Intervention	Phase
Bladder Cancer	Drug: Oxaliplatin Drug: Taxotere	Phase II

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Docetaxel Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

Further study details as provided by Stanford University:

Primary Outcome Measures:

** Response Rate - RECIST (Uni-Dimensional) Criteria

Secondary Outcome Measures:

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

Estimated Enrollment:	46
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186277

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Sanofi-Synthelabo

Investigators

Principal Investigator:

Dr. Sandy Srinivas

Stanford University

More Information

Study ID Numbers:	BLDR0001, BLDR0001, NCT00186277
Study First Received:	September 13, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00186277
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Oxaliplatin
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009