Clinical trial NCT01857817: Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
Official title: A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Vicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical benefit of the co-administration of propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Have a confirmed diagnosis of prostate cancer
2. Male participants who are ≥18 years of age
3. In the opinion of the investigator, the participants have a life expectancy of at least 3 months.
4. Two consecutively rising PSA values or two out of three rising PSA values (2.0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals
5. Have a Karnofsky Performance Score (KPS) equal to or greater than 70
6. Have the following laboratory parameters (may be assessed locally):

   1. Platelet count ≥50 x 10E3/µL
   2. Total bilirubin ≤1.5 mg/dL
   3. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance \>60 mL/min calculated using Cockcroft-Gault
   4. Liver enzymes \[aspartate transaminase (AST), alanine transaminase (ALT)\] ≤2 x ULN
7. Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice

Exclusion Criteria:

1. The patient has a history of another primary cancer, with the exception of:

   1. Curatively resected non-melanomatous skin cancer;
   2. Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis.
2. Contraindication to propranolol, etodolac
3. Patients on beta blockers
4. Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment
5. History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization
6. Hypotension at the time of screening (i.e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg)
7. Resting heart rate less than 60 bpm at time of screening
8. Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.
9. On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol)
10. Active clinically serious infections \[\> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\]
11. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results
12. Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of your face, lips, tongue, or throat)
13. Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study
14. Patients with uncontrolled diabetes or insulin resistance
15. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study

Primary outcomes:
measure: Change in prostate specific antigen (PSA)
timeFrame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)
Secondary outcomes:
measure: PSA progression
timeFrame: baseline to 12 weeks
measure: PSA doubling time (PSADT)
timeFrame: baseline and every month during treatment
measure: Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage)
timeFrame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
measure: Time to symptom progression (TTSP)
timeFrame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
measure: Change in correlative biomarkers
timeFrame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Parker
country: United States
facility: Advanced Urology
state: Colorado
city: Bradenton
country: United States
facility: Manatee Medical Research Institute, LLC
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Lansing
country: United States
facility: Detroit Clinical Research Center, PC
state: Michigan
city: Sartell
country: United States
facility: Adult & Pediatric Urology
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Abilene
country: United States
facility: Hendrick Cancer Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
Study officials:
References: