Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant

Status Terminated

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01469338
Study type	Interventional
Source	University of Southern California
Contact
Status	Terminated
Phase	Phase 2
Start date	July 2012
Completion date	November 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms