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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

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

NCTNCT01642732 (opens ClinicalTrials.gov in a new tab)Other idUMCC 2011.008Other idHUM00047650

Overview

Status
Terminated
Phase
Phase 1
Enrollment
1 participants (actual)
Sponsor
University of Michigan Rogel Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2012
Primary completion
Aug 2014
Completion
Aug 2014
First posted
17 Jul 2012 (estimated)
Last update posted
30 May 2017
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 1

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

    NCT01642732

    Oct 2012 to Aug 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purposes of this study are to: * Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be taken in combination with hormonal and radiation therapy in men with high risk prostate cancer. * Evaluate changes in patient reported quality of life * Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor. Biomarkers can also help determine areas for further research.

Interventions

  • Everolimus, lupron, bicalutamide, and radiationOther

Arms1

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

Secondary outcomes(1)
  1. Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus

    Time frame · Prior to treatment and at 14 days

    Registry description

    Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 64 months after beginning everolimus

Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation

GroupValue
Everolimus With Combined Hormonal and Radiation Therapynot posted
Secondary and other outcome results(1)
Secondary outcome· Prior to treatment and at 14 days

Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus

GroupValue
Everolimus With Combined Hormonal and Radiation Therapynot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Everolimus With Combined Hormonal and Radiation TherapyEverolimus - 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.–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age ≥ 18 years * Participants must be able to care for themselves * Adequate function * Adequate kidney function * Histologically confirmed diagnosis of adenocarcinoma of the prostate with biopsy within 90 days of enrollment * High-risk prostate cancer * No distant metastases as evaluated by a bone scan and CT of the pelvis (within 90 days of enrollment) * Participants must have at least 4 biopsy cores containing prostate cancer with tissue available for histologic analysis * Signed informed consent Exclusion Criteria: * Participants currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, targeted therapy, etc.) * Prior pharmacologic androgen ablation for prostate cancer is not allowed including LHRH agonist therapy or oral anti-androgen therapy. o Previous use of either finasteride or dutasteride is allowed * Participants, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, participants who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participants that may require major surgery during the course of the study * Any previous therapeutic radiation therapy to the pelvis. * Known gastrointestinal dysfunction or an inability to take oral medications that would preclude taking an oral medication. * Prior treatment with any investigational drug within the preceding 4 weeks of registration * Participants receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. o Topical or inhaled corticosteroids are allowed. * Participants should not receive immunization with attenuated live vaccines within one week of registration or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines. * Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin. * Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: * Symptomatic congestive heart failure of New York heart Association Class III or IV * Uncontrolled cardiac arrhythmia * The use of anti-arrhythmic medications or implanted pacemakers or defibrillators is allowed and would not exclude a patient from enrollment. * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease * Severely impaired lung function * Uncontrolled diabetes * Active (acute or chronic) or uncontrolled severe infections * Liver disease such as cirrhosis or severe hepatic impairment * Uncontrolled diabetes mellitus despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary; * A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all participants. * Participants with previous documented history of Hepatitis B/C infection are excluded from enrollment. * Participants with high risk for hepatitis based upon medical history and risk factors must be screened for Hepatitis B and C, and if positive are excluded from enrollment. * A known history of HIV seropositivity * Participants with an active, bleeding diathesis * Male patient whose sexual partner(s) are women of child bearing potential who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment * Participants who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus). o Sirolimus eluting coronary artery stents are allowed * Participants with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients * Participants unwilling to or unable to comply with the protocol

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