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The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00459186
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : March 3, 2014
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Metastatic, Androgen Independent Prostate Cancer Prostate Cancer Drug: RAD001 Drug: Docetaxel Drug: Prednisone Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
Study Start Date : November 2005
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RAD001 Followed by RAD001 + Docetaxel
RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
Drug: RAD001
Daily for two weeks
Drug: Docetaxel
Infusion once per cycle
Drug: Prednisone
Prednisone 5 mg by mouth twice daily

Outcome Measures

Primary Outcome Measures :
  1. Number of Patients Free of Dose Limiting Toxicity [ Time Frame: 21 days ]

    A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:

    Hematologic Toxicity:

    CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days

    Non-hematologic toxicity:

    The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:

    1. CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.
    2. CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)
    3. CTCAE grade 3 or 4 alkaline phosphatase.

Secondary Outcome Measures :
  1. Response Based on PET Scan [ Time Frame: 10 to 14 days after study entry ]
    Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459186

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Oregon Health and Science University
Principal Investigator: Mary Ellen Taplin, MD Dana-Farber Cancer Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00459186     History of Changes
Other Study ID Numbers: 05-184
First Posted: April 11, 2007    Key Record Dates
Results First Posted: March 3, 2014
Last Update Posted: May 16, 2016
Last Verified: April 2016

Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
prostate cancer
mTOR inhibition

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents