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A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic, Androgen Independent Prostate Cancer, Prostate Cancer

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Trial Information

A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

- Patients will be designated into one of two groups based upon the results of a FDG-PET

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose and toxicity of docetaxel and RAD001 in HRPC Response rate to docetaxol and RAD001 in HRPC

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Mary Ellen Taplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

December 2012

Related Keywords:

  • Metastatic, Androgen Independent Prostate Cancer
  • Prostate Cancer
  • prostate cancer
  • RAD001
  • mTOR inhibition
  • docetaxel
  • Prostatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Oregon Health Science University Portland, Oregon  97239