NCT00459186

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2014

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

7.1 years

First QC Date

January 23, 2006

Results QC Date

December 13, 2013

Last Update Submit

April 13, 2016

Conditions

Metastatic, Androgen Independent Prostate CancerProstate Cancer

Keywords

prostate cancerRAD001mTOR inhibitiondocetaxel

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Free of Dose Limiting Toxicity

    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.

    21 days

Secondary Outcomes (1)

  • Response Based on PET Scan

    10 to 14 days after study entry

Study Arms (1)

RAD001 Followed by RAD001 + Docetaxel

EXPERIMENTAL

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: RAD001Drug: DocetaxelDrug: Prednisone

Interventions

RAD001DRUG

Daily for two weeks

RAD001 Followed by RAD001 + Docetaxel
DocetaxelDRUG

Infusion once per cycle

RAD001 Followed by RAD001 + Docetaxel
PrednisoneDRUG

Prednisone 5 mg by mouth twice daily

RAD001 Followed by RAD001 + Docetaxel

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Oregon Health Science University

Portland, Oregon, United States

Location

Related Publications (1)

  • Courtney KD, Manola JB, Elfiky AA, Ross R, Oh WK, Yap JT, Van den Abbeele AD, Ryan CW, Beer TM, Loda M, Priolo C, Kantoff P, Taplin ME. A phase I study of everolimus and docetaxel in patients with castration-resistant prostate cancer. Clin Genitourin Cancer. 2015 Apr;13(2):113-23. doi: 10.1016/j.clgc.2014.08.007. Epub 2014 Oct 22.

    PMID: 25450031DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisProstatic Neoplasms

Interventions

EverolimusDocetaxelPrednisone

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Mary-Ellen Taplin
Organization
Dana-Farber Cancer Institute
Mary_Taplin@dfci.harvard.edu
617-632-3237

Study Officials

  • Mary Ellen Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, HMS

Study Record Dates

First Submitted

January 23, 2006

First Posted

April 11, 2007

Study Start

November 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 16, 2016

Results First Posted

March 3, 2014

Record last verified: 2016-04

Locations

US(5)