Status:
COMPLETED
The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Novartis
Massachusetts General Hospital
Conditions:
Metastatic, Androgen Independent Prostate Cancer
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00459186
Start Date
November 1 2005
End Date
December 1 2012
Last Update
May 16 2016
Active Locations (5)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215