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RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, February 2008

Sponsors and Collaborators: Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis
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

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Everolimus    Bicalutamide   

U.S. FDA Resources

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

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 Primary Completion Date:   February 2011 (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

Investigators
Study Chair:     Mary-Ellen Taplin, MD     Dana-Farber Cancer Institute    
  More Information

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

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

Study placed in the following topic categories:
Everolimus
Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Androgen Antagonists
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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