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Therapeutic Areas: Oncology | Nephrology | Urology | Family Medicine
Disease Category: Prostate Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E2809 Phase II Randomized Study of Bicalutamide With Versus Without Akt Inhibitor MK2206 in Patients With Prostate Cancer and Rising PSA at High-Risk of Progression After Primary Therapy

Purpose

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to compare the effects, good and/or bad, of MK-2206 and Bicalutamide (a type of hormonal therapy), versus Bicalutamide alone on lowering your PSA. In this study, you will receive either MK-2206 combined with Bicalutamide OR Bicalutamide alone. If you are selected to receive Bicalutamide alone, you will not be eligible to receive MK-2206 as part of this study. The study will also evaluate the safety of the Bicalutamide and MK-2206 combination therapy.

It is thought that the combination of drugs used in this study may slow or stop the rising of your PSA and prevent your cancer from coming back or keep it in remission for a longer period of time. MK-2206 is an investigational agent that has not been approved by the FDA (Food and Drug Administration) for use in prostate cancer. The use of MK-2206 in this clinical study is experimental.

Patient Inclusion Criteria:

  • Histologically confirmed prostate cancer
  • Must have had definitive surgery, radiotherapy, or cryoablation
  • Must have hormone-sensitive prostate cancer by evidence of a serum total testosterone level > 150 ng/dL within the past 12 weeks
  • Biochemical failure after primary therapy and subsequent progression determined by 1 of the following:
    1. PSA ≥ 0.4 ng/mL for patients who had radical prostatectomy
    2. PSA rise ≥ 2 ng/mL above the nadir PSA for patients who had radiotherapy
    3. Patients must have 2 subsequent PSA rises (PSA2 and PSA3) obtained ≥ 2 weeks apart and each having a value higher than the previous one, with a PSA doubling time (PSADT) in < 12 months
    4. Baseline PSA = 2 ng/mL and = 50 ng/mL

Patient Exclusion Criteria:

  • At least 14 days since prior enzyme-inducing anti-epileptic drugs (EIAED)
  • Non-EIAED allowed
  • More than 2 weeks since prior and no concurrent cytochrome P450 EIAED (phenytoin, carbamazepine, or phenobarbital), St John wort, ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, or grapefruit juice
  • No prior therapy modulating testosterone levels (such as luteinizing hormone, releasing-hormone agonists/antagonists, or antiandrogens) within the past year
  • Prior therapy modulating testosterone levels in the neoadjuvant and/or adjuvant setting allowed
  • Patients may have received targeted agents (angiogenesis inhibitors, EGFR inhibitors, mTOR inhibitors, PI3K inhibitors, etc.); however, patients must have discontinued treatment with the targeted agent(s) at least 4 weeks prior to enrollment
  • If the patient stopped targeted agent(s) due to unresolved or persistent grade 3 or 4 toxicity, patient cannot be enrolled onto the study regardless of the length of time since discontinuation of treatment with targeted agent(s)
  • No concurrent 5-alpha-reductase inhibitors, ketoconazole, abiraterone, MDV31000, megestrol acetate, systemic steroids, or herbal supplements
  • No concurrent therapeutic administration of anticoagulant therapy
  • Low-dosage aspirin ≤ 325 mg per day allowed
  • No other concurrent investigational agents or anticancer therapy (e.g., chemotherapy, immunotherapy, radiation therapy, surgery for cancer, or experimental medications)
  • No concurrent medications or substances that are inhibitors or inducers of CYP 450 3A4
  • No concurrent drugs with a risk of causing torsades de pointes
  • ECOG performance status 0-1

To Learn more
Phase

2

Gender

Male

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183155

Date Last Changed: July 17, 2013


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