This randomized phase II trial studies how well docetaxel works when given with or without ascorbic acid in treating patients with prostate cancer that has spread to other places in the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better when given with or without ascorbic acid in treating prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Given IV
Given IV
Correlative studies
Correlative studies
Given IV
Ancillary studies
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Anne Arundel Health System, Research Institute
Annapolis, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement
prostate-specific antigen decline will be defined as ≥ 50% from baseline measurement
Time frame: up to 24 weeks
Number of Participants With Adverse Events
Number of participants experiencing fatigue, nausea, bone pain, and anorexia as defined by CTCAE 4.0
Time frame: Up to 30 days after the last dose of study drug
Average Number of Times Docetaxel Had Dose Reductions
The number of dose reductions and total number of completed cycles will be summarized by study arm.
Time frame: Up to 24 weeks
Number of Serious Adverse Events
Number of serious adverse events of all types as defined by Common Terminology Criteria for Adverse Events 4.0. A serious adverse event is an undesirable sign, symptom, or medical condition that: * Results in death * Is life threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization for \>24 hours * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event
Time frame: Up to 30 days after last dose of study drug
Number of Participates Experiencing Serious Adverse Events (SAE)
Number of serious adverse events defined as grade 3 or higher (fatigue, nausea, bone pain, and anorexia) in participates as defined by CTCAE 4.0
Time frame: Up to 24 weeks
Change in Quality of Life (QoL) as Measured by the FACT-P Questionnaire
The (FACT-P) is made up of 39 question, with the total score ranging between 0 and 156 with 0 being the best and 156 as the worst.
Time frame: Up to course 6 of therapy (18 weeks)
Radiographic Progression Free Survival (rPFS)
To determine the rPFS of participates that receive at least one dose of ascorbic acid compared to those who received placebo
Time frame: Up to 3 years
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