Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer

NCT ID: NCT00943956

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus

Everolimus + radiation

Group Type: EXPERIMENTAL

bicalutamide

Intervention Type: DRUG

everolimus

Intervention Type: DRUG

leuprolide acetate

Intervention Type: DRUG

external beam radiation therapy

Intervention Type: RADIATION

Interventions

bicalutamide

Intervention Type: DRUG

everolimus

Intervention Type: DRUG

leuprolide acetate

Intervention Type: DRUG

external beam radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Azria, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Countries

France

Other Identifiers

CLCC-RHOMUS

Identifier Type: -

Identifier Source: secondary_id

CRAD001 C2486

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0921

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-003620-38

Identifier Type: -

Identifier Source: secondary_id

CDR0000639358

Identifier Type: -

Identifier Source: org_study_id