Back to resultsEverolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
bicalutamide
everolimus
leuprolide acetate
external beam radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of high-risk, locally advanced prostate cancer meeting ≥ 1 of the following criteria:
- Clinical stage ≥ T3
- Gleason score ≥ 8
- PSA ≥ 20 ng/mL
- Previously untreated disease
- Non-metastatic disease as assessed by bone scan and CT scan of the thorax and abdomen
- Negative pelvic lymph nodes as proven by pathological analysis
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- WBC ≥ 3.5 x 10^9/L
- ANC ≥ 1.5 x 10^9/L
- Platelets normal
- Hemoglobin > 10 g/dL
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Albumin ≥ 3 g/dL
- Serum transaminases activity ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Covered by national health insurance
- No history of previous malignant disease, except for adequately treated basal cell carcinoma of the skin
- No ≥ grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment, if given)
- No uncontrolled infection
- No dysphagia or intestinal malabsorption
- No other concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease [unstable angina], uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
- No history of noncompliance to medical regimens
- No known hypersensitivity to everolimus, sirolimus (rapamycin), or temsirolimus
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since prior investigational drugs
- More than 10 days since prior and no concurrent treatment with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
Sites / Locations
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Everolimus
Arm Description
Everolimus + radiation
Outcomes
Primary Outcome Measures
Acute and late toxicities
Secondary Outcome Measures
Biochemical-free survival
Metastasis-free survival
Overall survival
Pre-treatment molecular characteristics of the tumor and its correlation with outcomes
Full Information
NCT ID
NCT00943956
First Posted
July 21, 2009
Last Updated
May 24, 2016
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT00943956
Brief Title
Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
Official Title
A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.(RHOMUS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide, leuprolide acetate, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bicalutamide and leuprolide acetate in treating patients with high-risk locally advanced prostate cancer undergoing radiation therapy.
Detailed Description
OBJECTIVES:
Primary
To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer.
Secondary
To assess the biochemical-free survival of these patients.
To assess metastasis-free survival of these patients.
To assess the overall survival of these patients.
To assess the molecular characteristics of the tumor before treatment and correlate with outcomes.
OUTLINE: This is a dose-escalation study of everolimus.
Patients undergo radiotherapy to the prostate and seminal vesicles once daily, 5 days a week, for 7.5 weeks.
Beginning the week before radiotherapy, patients receive oral bicalutamide once daily for 1 month and oral everolimus twice daily for 8.5 weeks. Beginning on the first week of radiotherapy, patients receive leuprolide acetate subcutaneously every 3 months for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage III prostate cancer, stage IV prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Everolimus
Arm Type
Experimental
Arm Description
Everolimus + radiation
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Intervention Type
Radiation
Intervention Name(s)
external beam radiation therapy
Primary Outcome Measure Information:
Title
Acute and late toxicities
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biochemical-free survival
Time Frame
1 year
Title
Metastasis-free survival
Time Frame
1 year
Title
Overall survival
Time Frame
1 year
Title
Pre-treatment molecular characteristics of the tumor and its correlation with outcomes
Time Frame
1 year
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of high-risk, locally advanced prostate cancer meeting ≥ 1 of the following criteria:
Clinical stage ≥ T3
Gleason score ≥ 8
PSA ≥ 20 ng/mL
Previously untreated disease
Non-metastatic disease as assessed by bone scan and CT scan of the thorax and abdomen
Negative pelvic lymph nodes as proven by pathological analysis
PATIENT CHARACTERISTICS:
WHO performance status 0-1
WBC ≥ 3.5 x 10^9/L
ANC ≥ 1.5 x 10^9/L
Platelets normal
Hemoglobin > 10 g/dL
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
Albumin ≥ 3 g/dL
Serum transaminases activity ≤ 2.5 x ULN
Alkaline phosphatase ≤ 2.5 x ULN
Serum creatinine ≤ 1.5 x ULN
Covered by national health insurance
No history of previous malignant disease, except for adequately treated basal cell carcinoma of the skin
No ≥ grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment, if given)
No uncontrolled infection
No dysphagia or intestinal malabsorption
No other concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease [unstable angina], uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
No history of noncompliance to medical regimens
No known hypersensitivity to everolimus, sirolimus (rapamycin), or temsirolimus
No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 30 days since prior investigational drugs
More than 10 days since prior and no concurrent treatment with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Azria, MD, PhD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Learn more about this trial
Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
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