Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

This study has been terminated.
(Sponsor closed the trial)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00924807
First received: June 17, 2009
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.


Condition Intervention Phase
Prostate Cancer
Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • determine the safety and maximally tolerated dose of sorafenib administered concurrently with radiotherapy in the treatment of intermediate- and high-risk localized prostate cancer. [ Time Frame: Day 29 and every 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biochemical disease-free survival [ Time Frame: after 9 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androgen Depr, Radiotherapy, Sorafenib
Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Other Names:
  • Leuprolide acetate
  • Bicalutamide
  • Sorafenib

Detailed Description:

Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.
  • Age > 18 years.
  • Life expectancy of greater than 5 years.
  • Patients must have normal organ and marrow function.
  • No pelvic lymph node metastases based on pelvic CT scan or MRI.
  • No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

  • Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924807

Locations
United States, New York
St.Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
Beth Israel Medical Center
Bayer
Investigators
Principal Investigator: Seth Cohen, MD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00924807     History of Changes
Other Study ID Numbers: IRB# 004-08, SR06-959
Study First Received: June 17, 2009
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Prostate Cancer
Combined Androgen Blockade
Radiotherapy
Sorafenib

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sorafenib
Bicalutamide
Leuprolide
Androgens
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014