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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Metastatic Bladder Cancer  Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
For Condition: transitional cell carcinoma of the bladder,recurrent bladder cancer,recurrent transitional cell cancer of the renal pelvis and ureter,stage 4 bladder cancer,metastatic transitional cell cancer of the renal pelvis and ureter
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000067448; UCCRC-10020,NCI-T99-0009
Study Start Date: February 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004203
Other Recurrent Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
1. Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
2. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
3. Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer
4. Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
5. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
Related Studies:
Other recurrent transitional cell cancer of the renal pelvis and ureter Clinical Trials
Other Indiana Clinical Trials
Other Ft. Wayne Clinical Trials
Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
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