A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.
N/A
80 Years
Male
Prostate Cancer
Trial Information
A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Acute and late toxicities
Safety Issue:
Yes
Principal Investigator
David Azria, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
Unspecified
Study ID:
CDR0000639358
NCT ID:
NCT00943956
Start Date:
January 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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