Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

NCT00526591 | Terminated Phase 2 Results DMC

• 4 other identifiers: CASE21806P30CA043703CASE-21806CASE-21806-CC256
• Study Type: interventional
• Target: 17
• 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. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery

  Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders.

  After 8 weeks of therapy at the time of prostatectomy

• Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)

  Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)

  at daily dose for 8 weeks

Secondary Outcomes (1)

• Change in PSA

  Up to 16 weeks after start of study

Other Outcomes (1)

• Effect of Treatment on Biological and Molecular Markers

  After 8 weeks of therapy

Study Arms (2)

Low-dose Everolimus Cohort

EXPERIMENTAL

5mg Everolimus daily continuously for 8 weeks and conventional surgery

Drug: Everolimus; Procedure: conventional surgery

High-dose Everolimus Cohort

ACTIVE COMPARATOR

10mg Everolimus daily continuously for 8 weeks and conventional surgery

Drug: Everolimus; Procedure: conventional surgery

Interventions

Everolimus DRUG

Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week

Also known as: RAD-001

High-dose Everolimus Cohort; Low-dose Everolimus Cohort

conventional surgery PROCEDURE

Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).

High-dose Everolimus Cohort; Low-dose Everolimus Cohort

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 8 g/dL
• AST and ALT ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• PT/PTT normal (no anticoagulants)
• No active unresolved infection
• No known HIV positivity
• Fertile patients must use effective contraception during and for 6 months after completion of study therapy

You may not qualify if:

• Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus or temsirolimus) or to its excipients
• Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI function and alter the absorption of everolimus, including any of the following:
• Ulcerative disease
• Uncontrolled nausea
• Vomiting
• Diarrhea
• Malabsorption syndrome
• Other active malignancy or malignancy at ≥ 30% risk for relapse after completion of therapy, except nonmelanoma skin cancer
• Uncontrolled concurrent illness including, but not limited to, any of the following:
• Ongoing or active infection (e.g., bacterial, viral or fungal)
• Severely impaired lung function
• Uncontrolled diabetes (fasting serum glucose \> 1.5 times ULN)
• Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
• Symptomatic congestive heart failure
• Unstable angina pectoris

Sponsors & Collaborators

• Jorge A. Garcia, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Koshkin VS, Mir MC, Barata P, Gul A, Gupta R, Stephenson AJ, Kaouk J, Berglund R, Magi-Galluzzi C, Klein EA, Dreicer R, Garcia JA. Randomized phase II trial of neoadjuvant everolimus in patients with high-risk localized prostate cancer. Invest New Drugs. 2019 Jun;37(3):559-566. doi: 10.1007/s10637-019-00778-4. Epub 2019 Apr 30.

  PMID: 31037562 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Everolimus

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

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

garciaj4@case.edu

216-444-7774

Study Officials

• Jorge A. Garcia, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 10, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-11

Locations

US (1)