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Investigator(s):
William L. Dahut, M.D. Principal Investigator Phone: 301-435-8183 dahutw@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Marcia L. Mulquin, R.N. Research Nurse Phone: 301-435-5613 Fax: 301-402-7901 mmulquin@mail.nih.gov

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Primary Eligibility:

• Diagnosis of metastatic prostate cancer that has not responded to standard treatment, including surgical removal of the testicles or treatment with androgen (sex hormone) suppressing drugs
• Progression documented by any of the following:
• Two consecutively rising PSA levels 2 weeks apart
• At least one new lesion on bone scans
• Progressive measurable disease
• Must continue on GnRH agonist
• No prior chemotherapy or antiangiogenic therapy for metastatic prostate cancer; prior immunotherapy/vaccine, experimental hormonal therapy, radiation, and (neo)adjuvant chemotherapy permitted
• Patients receiving an anti-androgen agent for ≥ 6 months and entering the trial due to a rise in PSA must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide
• ≥ 18 years of age
• ECOG performance status 0–2
• Leukocytes ≥ 3,000/microL
• Absolute neutrophil count ≥ 1,500/microL
• Platelets ≥ 100,000/microL
• Total bilirubin ≤ 1.5 x institutional upper limits of normal (ULN), or ≤ 3 mg/dL with Gilbert syndrome
• AST and ALT ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min/1.73 m² for patients with creatinine levels > ULN
• Recovered from prior therapy
• No other active malignancy within the past 2 years with the exception of non-melanoma skin cancer and superficial bladder carcinoma
• Not pregnant or nursing; must agree to use adequate contraception prior to the study, during the study, and at least 6 months after study completion
• Must agree not to share study drug and not to donate blood, sperm, or semen
• Urine should be screened for urine protein creatinine (UPC) ratio; if UPC > 0.5, 24-hour urine protein should be obtained and the level should be < 1,000 mg
• No clinical signs or symptoms of current active brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan; previously treated brain metastases allowed if no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for ≥ 3 months
• No medical condition that would preclude study participation
• No prior history of hypertensive crisis or hypertensive encephalopathy
• No HIV-positive patients receiving combination anti-retroviral therapy
• No history of allergic reaction to docetaxel, prednisone, lenalidomide, and/or bevacizumab or related products
• Able to ingest oral medications
• No known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies

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Study Outline:

This is a single-stage Phase II study, with an early stopping rule for excessive toxicity.

• Participants will have a complete medical history and physical examination before beginning
• Patients will be treated with 21-day cycles with a combination of four drugs:
• Docetaxel given into a vein for 60 minutes on the first day of each 21-day cycle; patients take dexamethasone (a steroid agent) before and after taking docetaxel
• Prednisone taken by mouth daily
• Bevacizumab given through a vein over 30 to 90 minutes on the first day of each 21-day cycle following the infusion of docetaxel
• Lenalidomide taken by mouth during the first 2 weeks of each 21-day cycle (the dose of lenalidomide may be adjusted if side effects develop)
• Patients also receive enoxaparin, a subcutaneous injection administered daily to prevent blood clots, and pegfilgrastim (as needed), a subcutaneous injection on Day 2 of each cycle to improve white blood cell counts, as directed by researchers
• The goal is to enroll 45 patients at the 25 mg dose level of lenalidomide
• If 7 in the first 18 or fewer patients receiving lenalidomide at 25 mg develop grade 4 toxicity at anytime during study, no further patients will be enrolled
• If < 7 of the first 18 patients have toxicity, accrual will continue until 45 patients have been enrolled at the 25 mg dose level of lenalidomide
• A run-in phase with lenalidomide at 15 mg will be conducted in the first 3 patients and at 20 mg for the next 3 patients for assessing its tolerability within the combination prior to dosing at 25 mg thereafter

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 11/11/09