Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer

This study has been terminated.
(Lack of accrual and funding expires in June, 2014.)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01642732
First received: March 24, 2012
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: November 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Other: Everolimus, lupron, bicalutamide, and radiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Everolimus With Combined Hormonal and Radiation Therapy

Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.

Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).

Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.

Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.

Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study.


Participant Flow:   Overall Study
    Everolimus With Combined Hormonal and Radiation Therapy  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Everolimus With Combined Hormonal and Radiation Therapy

Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.

Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).

Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.

Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.

Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study.


Baseline Measures
    Everolimus With Combined Hormonal and Radiation Therapy  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 54 to 54 )  
Gender  
[units: participants]
 
Female     0  
Male     1  



  Outcome Measures

1.  Primary:   Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation   [ Time Frame: 64 months after beginning everolimus ]

2.  Secondary:   Correlation of Prostate Biomarkers With Serologic Everolimus Levels as Well as Changes From Pre- to Post-everolimus Will be Completed.   [ Time Frame: Biopsy before everolimus and 10-14 days after starting everolimus. Analysis will occur at the end of the study (about 5 years). ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only one patient was enrolled to the trial and consent was withdrawn prior to treatment therefore the primary objective could not be analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Hamstra, Associate Professor of Radiation Oncology
Organization: University of Michigan Hospital
phone: 734-936-4300
e-mail: dhamm@umich.edu


No publications provided


Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01642732     History of Changes
Other Study ID Numbers: UMCC 2011.008, HUM00047650
Study First Received: March 24, 2012
Results First Received: November 13, 2014
Last Updated: November 13, 2014
Health Authority: United States: Institutional Review Board