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A Phase II Study of Oxaliplatin in Urothelial Cancer

Phase 2
18 Years
Not Enrolling
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

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Trial Information

A Phase II Study of Oxaliplatin in Urothelial 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.

Inclusion 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

April 2005

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • recurrent transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Evanston Northwestern Health Care Evanston, Illinois  60201
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
University of Illinois at Chicago Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Division of Hematology/Oncology Park Ridge, Illinois  60068