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PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

NCT00313482 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-05-11

No results posted yet for this study

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.

Conditions

  • Hormone Refractory Prostate Cancer

Interventions

DRUG

Sargramostim

250 mcg/m2 SC days 2-15 of each cycle

DRUG

Docetaxel

75 mg/m2 IV over 1 hour on Day 1 of each cycle

DRUG

Prednisone

5 mg orally BID on Day 1 continuously

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Veeda Oncology

    lead OTHER

Principal Investigators

  • Evan R Berger, MD · North Shore Hematology Oncology Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313482 on ClinicalTrials.gov