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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004203 |
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 | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Oxaliplatin in Urothelial Cancer |
Study Start Date: | February 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Illinois | |
Cancer Care Specialists of Central Illinois, S.C. | |
Decatur, Illinois, United States, 62526 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Division of Hematology/Oncology | |
Park Ridge, Illinois, United States, 60068 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology/Oncology P.C. | |
South Bend, Indiana, United States, 46617 | |
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000067448, UCCRC-10020, NCI-T99-0009 |
Study First Received: | January 21, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004203 History of Changes |
Health Authority: | United States: Federal Government |
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 Tract Neoplasm Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Recurrence |
Carcinoma Oxaliplatin Renal Cancer Urologic Diseases Kidney Neoplasms Bladder Neoplasm Kidney Diseases Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Pharmacologic Actions Carcinoma |
Oxaliplatin Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Kidney Diseases Ureteral Neoplasms Neoplasms, Glandular and Epithelial |