Bladder CancerPhase 2NCT00004203
Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
A Phase 2 study testing oxaliplatin in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by University of Chicago at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
- What is being tested?
- oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Feb 2000to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States11 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
Canada3 sites
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: 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.
Read the 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.
- Being tested
- oxaliplatin
- Keywords
- 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
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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 Receives: Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startFeb 2000
- Primary completionFeb 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Walter M. Stadler, MD, FACP, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004203
- Sponsor's protocol ID
- 10020
- Other IDs
- UCCRC-10020, NCI-T99-0009
- Status last verified
- Sep 2013
- First submitted
- 21 Jan 2000
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin in Urothelial Cancer
- ClinicalTrials.gov ID
- NCT00004203
- Acronym / sponsor ID
- 10020
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Feb 2002 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 12 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: oxaliplatinOn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatin | Drug | Arm A |
Primary outcome
Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter M. Stadler, MD, FACP study chair
University of Chicago
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by University of Chicago at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.