This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer
PRIMARY OBJECTIVES: I. To evaluate the impact of octreotide in reducing the incidence of grade 2 or greater diarrhea in men receiving cabazitaxel plus prednisone for castration-resistant prostate cancer (CRPC) after docetaxel therapy. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Progression-free survival (PFS) (defined as the time between treatment start and the first date of progression as measured by objective tumor progression using the Response Evaluation Criteria In Solid Tumors (RECIST), pain progression or death). III. Prostate-specific antigen (PSA) response rate. IV. Objective response rate. V. Pain response. VI. Toxicity. OUTLINE: Patients receive cabazitaxel as intravenous (IV) infusion over 1 hour on day 1, prednisone by mouth (PO) every day (QD), and octreotide pamoate given as intramuscular (IM) injection on day 1. Patients also receive octreotide acetate as a subcutaneous (SC) injection three times a day (TID) on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, every 3 months until disease progression, and then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
9
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Development of Grade 2 plus diarrhea
Defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria as an increase in frequency of 4 or greater stools per day over baseline, incontinence, diarrhea warranting hospitalization or diarrhea limiting self-care activities of daily living (ADL). Baseline frequency will be defined in the pre-treatment assessment from cycle 1 as the maximum number of stools in one 24 hour period during the past 2 weeks. Any incidence of grade 2 or greater diarrhea during treatment or for up to 21 days after the last administration of cabazitaxel will be included in this endpoint.
Time frame: Baseline through 21 days after the last administration of cabazitaxel
Progression-Free Survival
Time frame: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter
Overall Survival
Time frame: At 1 month after completion of treatment, every 3 months until disease progression, and then every 6 months thereafter
RECIST response for patients with measurable disease
Time frame: Baseline, after every 4 courses, at the end of treatment, and then every 6 months
Prostate-Specific Antigen response
Time frame: Baseline, day 1 of each course, at the end of treatment, and then every 6 months
Pain palliation in patients with a baseline pain score greater or equal to 2
Time frame: Baseline, day 1 of each 3 week course, at the end of treatment, and then every 6 months for up to 52 weeks
Toxicity (adverse events considered to be at least possibly drug-related)
Time frame: Baseline, day 1 of each course, and at the end of treatment
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