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
Recruitment status was Recruiting
Sponsor:
Centre Val d'Aurelle - Paul Lamarque
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
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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) |
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
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 Everolimus Sirolimus Bicalutamide Leuprolide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Antineoplastic Agents, Hormonal Fertility Agents, Female Fertility Agents Reproductive Control Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013