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Trial record 53 of 58344 for:    Placebo

Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT00393796
Recruitment Status : Terminated (Low accrual)
First Posted : October 30, 2006
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: SUTENT Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Study Start Date : May 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: SU011248

Placebo Comparator: 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.
Drug: 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.
Other Name: SU011248

Other: Placebo



Primary Outcome Measures :
  1. Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo [ Time Frame: 6 Months Post Treatment ]

    The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.

    Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
  • 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:

  • Major surgery within 4 weeks of starting the study treatment.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393796


Locations
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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Pfizer
Investigators
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Principal Investigator: Maha H. Hussain, M.D. University of Michigan Rogel Cancer Center

Publications of Results:
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00393796     History of Changes
Other Study ID Numbers: UMCC 2005.145
First Posted: October 30, 2006    Key Record Dates
Results First Posted: November 13, 2014
Last Update Posted: November 13, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action