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Trial record 23 of 1450 for:    prostate cancer AND radiation

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

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ClinicalTrials.gov Identifier: NCT01642732
Recruitment Status : Terminated (Lack of accrual and funding expires in June, 2014.)
First Posted : July 17, 2012
Results First Posted : November 20, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Other: Everolimus, lupron, bicalutamide, and radiation
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Everolimus With Combined Hormonal and Radiation Therapy
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Everolimus With Combined Hormonal and Radiation Therapy
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
54
(54 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation
Hide Description [Not Specified]
Time Frame 64 months after beginning everolimus
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was enrolled and withdrew from the study prior to treatment. The primary objective was not analyzed.
Arm/Group Title Everolimus With Combined Hormonal and Radiation Therapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus
Hide Description Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.
Time Frame Prior to treatment and at 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was enrolled and withdrew from the study prior to treatment. The objective was not analyzed.
Arm/Group Title Everolimus With Combined Hormonal and Radiation Therapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Only one patient was enrolled and the patient withdrew consent prior to treatment therefore Adverse Events (AEs) and Serious Adverse Events (SAEs) could not be analyzed.
 
Arm/Group Title Everolimus With Combined Hormonal and Radiation Therapy
Hide Arm/Group Description

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.

All-Cause Mortality
Everolimus With Combined Hormonal and Radiation Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus With Combined Hormonal and Radiation Therapy
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus With Combined Hormonal and Radiation Therapy
Affected / at Risk (%)
Total   0/0 
Only one patient was enrolled to the trial and consent was withdrawn prior to treatment therefore the primary objective could not be analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Hamstra, Associate Professor of Radiation Oncology
Organization: University of Michigan Hospital
Phone: 734-936-4300
EMail: dhamm@umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01642732     History of Changes
Other Study ID Numbers: UMCC 2011.008
HUM00047650 ( Other Identifier: Univ Mich Medical School Institutional Review Board (IRBMED) )
First Submitted: March 24, 2012
First Posted: July 17, 2012
Results First Submitted: November 13, 2014
Results First Posted: November 20, 2014
Last Update Posted: May 30, 2017