Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
|Diarrhea Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer||Drug: cabazitaxel Drug: prednisone Drug: octreotide pamoate Other: questionnaire administration Drug: octreotide acetate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel|
- Development of Grade 2 plus diarrhea [ Time Frame: Baseline through 21 days after the last administration of cabazitaxel ]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.
- 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 ]
|Study Start Date:||July 2012|
|Study Completion Date:||November 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (management of therapy complications)
Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC 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.
Other Names:Drug: prednisone
Other Names:Drug: octreotide pamoate
Other Names:Other: questionnaire administration
Ancillary studiesDrug: octreotide acetate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469338
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Jacek Pinski||University of Southern California|