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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00943956
First received: July 21, 2009
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: everolimus
Drug: leuprolide acetate
Radiation: external beam radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Acute and late toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biochemical-free survival [ Designated as safety issue: No ]
  • Metastasis-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Pre-treatment molecular characteristics of the tumor and its correlation with outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943956

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: David Azria, MD, PhD    33-4-6761-3132    David.Azria@valdorel.fnclcc.fr   
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: David Azria, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00943956     History of Changes
Other Study ID Numbers: CDR0000639358, CLCC-RHOMUS, CRAD001 C2486, INCA-RECF0921, EUDRACT-2007-003620-38
Study First Received: July 21, 2009
Last Updated: July 28, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Bicalutamide
Sirolimus
Everolimus
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on September 30, 2014