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Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer

Patients will undergo a screening procedure to determine eligibility of trial. During the
treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by
RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able
to continue to receive multiple treatment courses as long as the cancer does not get worse
and the person does not develop other problems that would prevent him from staying in the
study. The final part of the research is the study completion period which includes an end
of treatment visit and subsequent follow-up visits. These visits take place whenever the
research medication is stopped, even if it is stopped early. For the patient's safety,
he/she should at least complete the end of treatment visit.

Inclusion Criteria:

- Age ≥ 18 years.

- Signed informed consent

- ECOG performance status: 0-2

- Histologically documented adenocarcinoma of the prostate

- Progressive disease despite androgen deprivation therapy. Progressive disease is
defined as any one of the following:

- Measurable Disease: Objective evidence of increase > 20% in the sum of the longest
diameters of target lesions from the time of maximal regression or the appearance of
one or more new lesions (Modified RECIST Criteria)

- Bone Scan Progression: Appearance of one or more new lesions on bone scan
attributable to prostate cancer

- PSA Progression: An elevated PSA (≥ 5 ng/ml) which has risen serially from baseline
on two occasions each at least one week apart

- At least 4 weeks since any other hormonal therapy. Flutamide and megestrol acetate
(any dose) must be discontinued at least 4 weeks prior to initiating treatment.
Bicalutamide or nilutamide must be discontinued at least 6 weeks prior to initiating
treatment. If improvement following antiandrogen withdrawal is noted, progression
must be established using the criteria above. Androgen suppression should be

- ≥ 4 weeks since major surgery and fully recovered

- ≥ 8 weeks since high risk surgery and fully recovered

- ≥ 4 weeks since any prior radiation and fully recovered

- ≥ 6 weeks since the last dose of bone targeted radiopharmaceutical

- Men of child-bearing potential are required to use an effective means of

- Required Initial Laboratory Values:

- ANC ≥ 1500/µL

- Platelet count ≥ 100,000/µL

- Creatinine ≤ 1.5 x ULN

- Bilirubin ≤ 1.5 x ULN

- AST ≤ 1.5 x ULN

- Urine protein to creatinine ratio < 1.0

- Serum Testosterone ≤ 50 ng/dL (For patients who have not had bilateral

Exclusion Criteria:

- Prior treatment with cytotoxic chemotherapy for metastatic disease

- Prior treatment with anti-angiogenic agents, including thalidomide and bevacizumab

- Prior treatment with any investigational drug within 4 weeks of initiating treatment

- Prior treatment with an mTor inhibitor

- Chronic treatment with systemic steroids or another immunosuppressive agent

- Known history of HIV seropositivity

- Known brain metastases (brain imaging is not required)

- Congestive heart failure

- Uncontrolled hypertension. Patients with history of hypertension must be well
controlled (< 150/100) on a regimen of anti-hypertensive therapy

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Active bleeding diathesis or on oral anti-vitamin K medications (except low dose

- Arterial thrombotic events, including transient ischemic attack (TIA),
cerebrovascular accident (CVA), at any time

- History of unstable angina or angina requiring surgical or medical intervention in
the past 12 months, or myocardial infarction (MI)

- Patients with clinically significant peripheral artery disease or any other arterial
thrombotic event

- Significant vascular disease

- Other concurrent severe and/or uncontrolled medical disease which could compromise
participation in the study

- Proteinuria at screening as demonstrated by either

- Urine protein:creatinine (UPC) ratio ≥ 1.0 OR

- Urine dipstick for proteinuria ≥ 2+

- Serious or non-healing wound, ulcer or bone fracture

- Peripheral neuropathy ≥ grade 2

- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- Herbal medications and food supplements must be discontinued before registration.
Patients may continue on daily vitamins and calcium supplements

- History of noncompliance to medical regimens

- Unwilling to or unable to comply with the protocol

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab

Outcome Time Frame:

After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab

Safety Issue:


Principal Investigator

Mitchell E Gross, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

April 2015

Related Keywords:

  • Prostate Cancer
  • RAD001
  • mTOR inhibition
  • docetaxel
  • bevacizumab
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • prostate cancer
  • Metastatic, androgen independent prostate cancer
  • Prostatic Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Westside Prostate Cancer Center, University of Southern California Beverly Hills, California  90211