Oxaliplatin in Treating Patients With Metastatic Bladder Cancer

September 4, 2013 updated by: University of Chicago

A Phase II Study of Oxaliplatin in Urothelial Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Health Care
      • Park Ridge, Illinois, United States, 60068
        • Division of Hematology/Oncology
      • Peoria, Illinois, United States, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Springfield, Illinois, United States, 62701
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Inc.
      • South Bend, Indiana, United States, 46617
        • Michiana Hematology/Oncology P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
On Day 1 of each 21-day treatment cycle, patients receive 130 mg/m2 oxaliplatin diluted in 250 to 500 mL Dextrose 5% in Water infused intravenously over 2 hours through a peripheral or central vein
Drug: oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (ACTUAL)

February 1, 2002

Study Completion (ACTUAL)

April 1, 2005

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

February 11, 2004

First Posted (ESTIMATE)

February 12, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10020 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • UCCRC-10020
  • NCI-T99-0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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