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RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, January 2009
First Received: February 28, 2008   Last Updated: January 6, 2009   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborators: Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00630344
  Purpose

The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.


Condition Intervention Phase
Prostate Cancer
Drug: RAD001
Drug: Bicalutamide
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the best overall response and duration of response, taking into consideration measurable disease, bone metastases and PSA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the toxicity profile of RAD001 in combination with standard dose bicalutamide in patients with androgen independent prostate cancer. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: February 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: RAD001
    Taken orally once daily
    Drug: Bicalutamide
    Taken orally once daily
Detailed Description:
  • Participants will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks during which time participants will take RAD001 and bicalutamide orally, once per day. RAD001 will be provided from the research pharmacy at the hospital and a prescription will be given for bicalutamide to obtain from a local pharmacy.
  • A history, physical exam, and blood tests will be performed every four weeks. An assessment of the tumor by Chest CT scan, chest x-ray, bone scan, and abdomen/pelvis CT or MRI will be performed every 12 weeks.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically documented prostate cancer
  • Castration resistant prostate cancer defined as two rising PSAs on castration therapy
  • Baseline PSA of 2ns/mL or greater
  • Testosterone of 50ng/mL or less
  • Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
  • Prior bicalutamide is allowed as long as treatment was for 6 months or longer
  • Metastatic disease is not required
  • Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  • ECOG Performance Status equal to or less than 2
  • Adequate bone marrow and liver function as outlined by parameters in the protocol

Exclusion Criteria:

  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Prior treatment with an mTOR inhibitor
  • Fasting lipids over the parameters outlined in the protocol
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
  • Men able to conceive and unwilling to practice an effective method of birth control
  • Known hypersensitivity to RAD001 or other rapamycins or to its excipients
  • History of noncompliance to medical regimens
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630344

Contacts
Contact: Mary-Ellen Taplin, MD 617-632-5092
Contact: Geoffrey Buckle 617-632-5287

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Mary-Ellen Taplin, MD            
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Glenn Bubley, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Investigators
Study Chair: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Dana-Farber Cancer Institute ( Mary Ellen Taplin, MD )
Study ID Numbers: 07-316
Study First Received: February 28, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00630344     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
RAD001
bicalutamide
androgen independent prostate cancer

Additional relevant MeSH terms:
Everolimus
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Immunosuppressive Agents
Hormones
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 27, 2009