NCT01469338

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	cabazitaxel	Given IV
DRUG	prednisone	Given PO
DRUG	octreotide pamoate	Given IM
OTHER	questionnaire administration	Ancillary studies
DRUG	octreotide acetate	Given SC

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2011-11-10
• Last updated: 2014-11-24

Locations

1 site across 1 country: United States