Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
NCT ID: NCT00393796
Last Updated: 2014-11-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2006-05-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SUTENT
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Placebo
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Placebo
Interventions
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SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
* Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
* Reports from pre and post treatment imaging will be required at time of registration to document response.
* Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
* Patients may have received previous adjuvant or neoadjuvant therapy.
* No prior antiangiogenic therapy for this stage of the disease.
Exclusion Criteria
* NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
* History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
* Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
* Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Patients with history of or who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA(obtained within one month of registration or the next business day if falls on a weekend or holiday).
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \> 2.
* Unresolved bacterial infection.
* Uncontrolled hypertension.
* Pre-existing thyroid abnormality that can not be controlled medically.
* Concurrent treatment on another clinical trial.
* Pregnant or breast-feeding
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Maha H. Hussain, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
The University of Chicago
Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Weill Medical College of Cornell University
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Grivas PD, Daignault S, Tagawa ST, Nanus DM, Stadler WM, Dreicer R, Kohli M, Petrylak DP, Vaughn DJ, Bylow KA, Wong SG, Sottnik JL, Keller ET, Al-Hawary M, Smith DC, Hussain M. Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma. Cancer. 2014 Mar 1;120(5):692-701. doi: 10.1002/cncr.28477. Epub 2013 Nov 18.
Other Identifiers
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UMCC 2005.145
Identifier Type: -
Identifier Source: org_study_id
NCT01225848
Identifier Type: -
Identifier Source: nct_alias