Status:
COMPLETED
Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 80 years
Phase:
PHASE1
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 canc...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00943956
Start Date
January 1 2009
End Date
December 1 2012
Last Update
May 25 2016
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298