A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
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.
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Baseline through 21 days after the last administration of cabazitaxel
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|