Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00526591

Run by

Jorge A. Garcia, MD

People needed

17

Starts

2007-09-01

Expected to finish

2011-08-01

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

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
• Cardiac arrhythmia
• Psychiatric illness or social situation that would limit study compliance
• Any underlying medical condition which, in the principal investigator's opinion, will make the administration of everolimus hazardous OR obscure the interpretation of adverse events
• PRIOR CONCURRENT THERAPY:
• More than 4 weeks since major surgery
• More than 3 months since finasteride
• No prior or concurrent radiotherapy to the prostate gland or pelvis
• No prior hormones (e.g., luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, or antiandrogens [e.g., bicalutamide, flutamide, or nilutamide]) and/or PC-SPES (or PC-x product) or estrogen-containing nutraceuticals
• No prior rapamycin mTOR inhibitor
• No prior small bowel resection that may significantly impair GI function and alter the absorption of everolimus

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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