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

NCT00943956 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000639358CLCC-RHOMUSCRAD001 C2486INCA-RECF0921EUDRACT-2007-003620-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Acute and late toxicities

  1 year

Secondary Outcomes (4)

• Biochemical-free survival

  1 year

• Metastasis-free survival

  1 year

• Overall survival

  1 year

• Pre-treatment molecular characteristics of the tumor and its correlation with outcomes

  1 year

Study Arms (1)

Everolimus

EXPERIMENTAL

Everolimus + radiation

Drug: bicalutamide; Drug: everolimus; Drug: leuprolide acetate; Radiation: external beam radiation therapy

Interventions

bicalutamide DRUG

Everolimus

everolimus DRUG

Everolimus

leuprolide acetate DRUG

Everolimus

external beam radiation therapy RADIATION

Everolimus

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

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

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Everolimus; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• David Azria, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

FR (1)