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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 29, 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

Tracking Information
First Submitted Date  ICMJE October 27, 2006
First Posted Date  ICMJE October 29, 2006
Results First Submitted Date  ICMJE June 19, 2014
Results First Posted Date  ICMJE November 13, 2014
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE May 2006
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Official Title  ICMJE Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Brief Summary This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: SUTENT
  • 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.
    Interventions:
    • Drug: SUTENT
    • Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2014)
54
Original Enrollment  ICMJE
 (submitted: October 27, 2006)
84
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393796
Other Study ID Numbers  ICMJE UMCC 2005.145
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Maha H. Hussain, M.D. University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP