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The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: January 23, 2006   Last Updated: January 6, 2009   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
Novartis
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Oregon Health and Science University
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00459186
  Purpose

The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).

Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).


Condition Intervention Phase
Metastatic, Androgen Independent Prostate Cancer
Prostate Cancer
Drug: RAD001
Drug: Docetaxel
Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Everolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

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

Primary Outcome Measures:
  • Dose and toxicity of docetaxel and RAD001 in HRPC Response rate to docetaxol and RAD001 in HRPC [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response based on PET scan [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: RAD001
    Daily for two weeks
    Drug: Docetaxel
    Infusion once per cycle
Detailed Description:
  • Patients will be designated into one of two groups based upon the results of a FDG-PET scan.
  • A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks. On day 10-14, another FDG-PET scan and serum assessment will be performed. An optional bone marrow biopsy may also be done. On day 15, patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II.
  • A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling.
  • Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks.
  • Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks.
  • The maximum duration of the trial is one year of therapy.
  Eligibility

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

Inclusion Criteria:

  • Adenocarcinoma of the prostate with radiographic evidence of metastatic disease.
  • Willingness to undergo a baseline tumor biopsy.
  • Castrate levels of testosterone (testosterone < 50 ng/dL) on androgen deprivation therapy (ADT) with evidence of progression on ADT. GnRH therapy will be continued for those on it at baseline
  • Patient must have suspected tumor in an area that is safe to biopsy.
  • Other prior hormonal interventions or experimental approaches are allowed. These therapies must have been discontinued for a minimum of 28 days with cancer progression.
  • Prior or concurrent use of bisphosphonates is allowed.
  • One prior non-taxane chemotherapy allowed
  • ≥ 3 weeks since major surgery; ≥ 4 weeks since radiotherapy; ≥ 8 weeks since prior strontium-89 or samarium 153
  • Performance Status: ECOG 0 or 1
  • ANC > 1,500/_l; platelets > 100,000/_l; total Bilirubin < upper limit of normal; AST and ALT < 3 x upper limits of normal; creatinine < 1.5 x upper limits of normal; total fasting cholesterol < 350 mg/dl; total triglycerides < 300 mg/dl

Exclusion Criteria:

  • Ongoing oral steroid use. Patients with a history of oral steroid use are eligible as long as the steroids have been discontinued prior to study entry. Ongoing topical and/or inhaled steroid use is allowed.
  • Prior taxane chemotherapy
  • Prior mTOR inhibitors (RAD001, rapamycin, CCI-779)
  • Currently active second malignancy other than non-melanoma skin cancer.
  • Ongoing peripheral neuropathy of Grade 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459186

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States
Sponsors and Collaborators
Dana-Farber Cancer Institute
Novartis
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Oregon Health and Science University
Investigators
Principal Investigator: 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: 05-184
Study First Received: January 23, 2006
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00459186     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
prostate cancer
RAD001
mTOR inhibition
docetaxel

Study placed in the following topic categories:
Everolimus
Docetaxel
Immunologic Factors
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Immunosuppressive Agents
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:
Everolimus
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Immunosuppressive Agents
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009