A Phase II Study of Oxaliplatin in Urothelial Cancer
18 Years
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
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:
Interventional
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:
No
Principal Investigator
Walter M. Stadler, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
University of Chicago
Authority:
United States: Federal Government
Study ID:
10020
NCT ID:
NCT00004203
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
Name | Location |
|---|---|
| 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 |
