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.

Condition	Treatment or Intervention	Phase
transitional cell carcinoma of the bladder recurrent bladder cancer stage IV bladder cancer recurrent transitional cell cancer of the renal pelvis and ureter metastatic transitional cell cancer of the renal pelvis and ureter	Procedure: chemotherapy  Drug: oxaliplatin	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

Illinois
      Cancer Care Specialists of Central Illinois, S.C., Decatur,  Illinois,  62526,  United States
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States
      Division of Hematology/Oncology, Park Ridge,  Illinois,  60068,  United States
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  United States
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  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
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Indiana
      Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne,  Indiana,  46885-5099,  United States
      Michiana Hematology/Oncology P.C., South Bend,  Indiana,  46617,  United States
Pennsylvania
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Canada, Ontario
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada

Study chairs or principal investigators

Walter M. Stadler,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000067448; UCCRC-10020; NCI-T99-0009
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  January 21, 2000
ClinicalTrials.gov Identifier:  NCT00004203
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08