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

NCT00924807 | Terminated Phase 1 Results

• 2 other identifiers: IRB# 004-08SR06-959
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Combined Androgen Blockade; Radiotherapy; Sorafenib

Outcome Measures

Primary Outcomes (1)

• Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.

  Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

  Day 29 and every 2 weeks

Secondary Outcomes (1)

• Biochemical Disease-free Survival

  after 9 months

Study Arms (1)

Androgen Depr, Radiotherapy, Sorafenib

EXPERIMENTAL

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Drug: Leuprolide acetate, Bicalutamide, Sorafenib

Interventions

Leuprolide acetate, Bicalutamide, Sorafenib DRUG

Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Also known as: Leuprolide acetate, Bicalutamide, Sorafenib

Androgen Depr, Radiotherapy, Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• Bayer: collaborator

Study Sites (1)

St.Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; bicalutamide; Sorafenib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study. Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Seth Cohen, MD
• Organization: St. Luke's Roosevelt Hospital Center

secohen@chpnet.org

212-523-7289

Study Officials

• Seth Cohen, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 11, 2018
• Results First Posted: March 17, 2015

Record last verified: 2018-11

Locations

US (1)