Spots Global Cancer Trial Database for PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC
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Trial Identification
Brief Title: PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC
Official Title: A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer
Study ID: NCT00313482
Conditions
Study Description
Brief Summary: This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs: * Docetaxel 75 mg/m2 IV given over 1 hour on Day 1. * Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression. * Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every 4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate the safety of this drug combination, patients will be evaluated at each clinic visit for adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE Version 3.0. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive a maximum of 10 cycles of treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Veeda Oncology, Columbus, Ohio, United States
Contact Details
Name: Evan R Berger, MD
Affiliation: North Shore Hematology Oncology Associates
Role: PRINCIPAL_INVESTIGATOR
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