A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer

Completed · Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

Background: * Prednisone and docetaxel have been used successfully in treating patients with prostate cancer, either when used alone or in combination with other agents. Researchers believe that these anticancer effects can be increased by giving them in this specific combination. * A previous study at the National Cancer Institute combined docetaxel and prednisone with bevacizumab and thalidomide. The results of this study were promising; however, most patients in the study required a dose reduction of thalidomide because of its side effects. * Lenalidomide, a drug similar to thalidomide, may have less severe side effects. Based on previous studies, lenalidomide is well tolerated in patients with solid tumors when used alone or in combination with docetaxel, and it may be a good substitute for thalidomide. Objectives: * To determine if lenalidomide is an appropriate and effective substitute for thalidomide in treating prostate cancer. * To evaluate the safety and effectiveness of bevacizumab, lenalidomide, docetaxel, and prednisone as a prostate cancer treatment, and to study any side effects. Eligibility: \- Men 18 years of age and older who have been diagnosed with metastatic prostate cancer that has not responded to standard treatment, including surgical removal of the testicles or treatment with androgen (sex-hormone) suppressing drugs. Design: * Participants will have a complete medical history and physical examination before beginning the study. * Patients will be treated with 21-day cycles with a combination of four drugs: * (1) Docetaxel, which will be given into a vein for 60 minutes on the first day of each 21-day cycle. Patients will take dexamethasone (a steroid agent) before and after taking docetaxel. * (2) Prednisone, which will be taken by mouth daily. * (3) Bevacizumab, which will be given through a vein over 30 to 90 minutes on the first day of each 21-day cycle following the infusion of docetaxel. * (4) Lenalidomide, which will be 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 will also receive enoxaparin, a subcutaneous injection administered daily, to prevent blood clots and/or pegfilgrastim, a subcutaneous injection on day 2 of each cycle, to improve white blood cell counts, as directed by researchers.

Key facts

Study ID: NCT00942578
Run by: National Cancer Institute (NCI)
People needed: 63
Starts: 2009-07-16
Expected to finish: 2017-07-31
Last updated by the study team: 2018-10-11

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

Present clinical signs or symptoms of current active brain and/or leptomeningeal metastases confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) brain scan. Patients with previously treated brain metastases are allowed to participate in the study.
-Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (MRI or CT). (Stable dose of anticonvulsants are allowed). Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, term linear accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician. Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
Uncontrolled, intercurrent illness including, but not limited to, symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse), unstable angina pectoris
Psychiatric illness/social situations that would limit compliance with study requirements.
Prior history of hypertensive crisis or hypertensive encephalopathy
Proteinuria, as demonstrated by a 24 hour protein of greater than or equal to 2000 mg. Urine protein should be screened by urine analysis. If urine dipstick is greater than 1.0+, then a 24 hour urine collection for total protein will need to be obtained and the level should be less than 2000 mg for patient enrollment.
Serious, non-healing wound, active ulcer, or untreated bone fracture, including tumor-related pathological fracture
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel, bevacizumab, and/or the combination.
Greater than Grade 2 peripheral neuropathy at baseline
History of allergic reaction to docetaxel, prednisone, lenalidomide and/or bevacizumab or related products.
Patients who are unable to ingest oral medication.
Patients on treatment for venous thromboembolism (VTE).
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy
Anticipation of need for major surgical procedures during the course of the study
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to Day 1
Patients with clinically significant cardiovascular disease are excluded
Inadequately controlled hypertension (HTN) (systolic blood pressure (SBP) greater than 160 mmHg and/or diastolic blood pressure (DBP) greater than 90 mmHg despite antihypertensive medication)
History of cerebrovascular accident (CVA) within 6 months (see additional requirement for adjuvant protocols), myocardial infarction or unstable angina within 6 months (see additional requirement for adjuvant protocols)
New York heart association grade II or greater congestive heart failure
Serious and inadequately controlled cardiac arrhythmia
Clinically significant vascular disease as stated above
Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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