Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients

NCT00879619 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-02-01

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells.

PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.

Conditions

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

DRUG

sunitinib malate

Given PO

DRUG

docetaxel

Given IV

DRUG

prednisone

Given PO

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • John P. Fruehauf

    lead OTHER

Principal Investigators

  • John P Fruehauf, MD, PhD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00879619 on ClinicalTrials.gov