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Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
This study is ongoing, but not recruiting participants.
Study NCT00004203   Information provided by National Cancer Institute (NCI)
First Received: January 21, 2000   Last Updated: July 23, 2008   History of Changes

January 21, 2000
July 23, 2008
February 2000
 
 
 
Complete list of historical versions of study NCT00004203 on ClinicalTrials.gov Archive Site
 
 
 
Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
A Phase II Study of Oxaliplatin in Urothelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have metastatic bladder cancer.

OBJECTIVES: I. Determine the response rate, duration of response, and overall survival of patients with metastatic urothelial carcinoma treated with oxaliplatin. II. Determine the toxicity, including objective measurement of neurotoxicity, of oxaliplatin in these patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by platinum therapy status (platinum sensitive vs platinum resistant). Patients receive oxaliplatin IV over 2 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression, other illness that would preclude administration of study drug, or unacceptable toxicity. Patients are followed for a minimum of 2 years or until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Phase II
Interventional
Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: oxaliplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic urothelial carcinoma Bidimensionally measurable disease Platinum sensitive OR platinum resistant Platinum sensitive disease: No prior platinum containing regimen OR Progressive or recurrent disease more than 6 months after responding to a platinum containing regimen Platinum resistant disease: Progressive or recurrent disease within 6 months of a platinum containing regimen (cisplatin or carboplatin) No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 30 mL/min Cardiovascular: No uncontrolled concurrent illness including, but not limited to: Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Other: No clinical evidence of neuropathy worse than grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics No uncontrolled concurrent illness including, but not limited to, an active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during the first course of study therapy Chemotherapy: See Disease Characteristics One prior chemotherapy regimen for metastatic disease allowed Prior neoadjuvant or adjuvant chemotherapy regimen allowed if the interval between this therapy and the first therapy for metastatic disease was at least 6 months At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No HIV positive patients receiving antiretroviral therapy

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00004203
 
CDR0000067448, UCCRC-10020, NCI-T99-0009
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
National Cancer Institute (NCI)
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP