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Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Pfizer
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00631527
  Purpose

Primary Objective:

1. To define the tolerability of three different dose-levels of the angiogenesis inhibitor, sunitinib malate, in combination with hormone ablation and external beam radiation for high-risk and locally advanced prostate cancer.

Secondary:

  1. Describe the qualitative and quantitative toxicity including serial quality of life changes.
  2. Evaluate putative biomarkers of outcome at baseline, after sunitinib lead-in and at 12 and 24 months after completion of radiation therapy.

Condition Intervention Phase
Prostate Cancer
Drug: Leuprolide
Drug: Goserelin
Drug: Sunitinib Malate
Drug: Bicalutamide
Radiation: Radiation Therapy
Phase I

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Sunitinib    Sunitinib malate    Goserelin    Leuprolide acetate    Leuprolide    Bicalutamide    Malic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   18
Study Start Date:   February 2008
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy
Drug: Leuprolide
Injections given through a needle in the muscle every 3 months.
Drug: Goserelin
Subcutaneous injections given once every 3 months.
Drug: Sunitinib Malate
12.5 mg PO daily for 4 weeks
Drug: Bicalutamide
PO daily for 2 weeks.
Radiation: Radiation Therapy
Radiation treatment once daily over a period of 8 weeks.

Show detailed description  Show Detailed Description

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

Criteria

Inclusion Criteria:

  1. Adenocarcinoma of the prostate with the following high-risk features are eligible: cT2c (palpable disease on digital rectal examination in both lobes) and Gleason Grade 7 (4+3) or higher with any PSA OR T3 or T4 disease of any Gleason Grade
  2. Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
  3. ECOG Performance Status 0-1
  4. Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x UNL, Total bilirubin WNL.
  5. No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease and collagen vascular disease.
  6. Patients must be at least 18 years of age

Exclusion Criteria:

  1. Prior VEGFR/PDGFR inhibitor or other investigational therapy.
  2. Inability to take oral medication
  3. Uncontrolled hypertension (blood pressure > 140/90 mm Hg despite optimal medical therapy), Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
  4. Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631527

Contacts
Contact: Paul Mathew, MD     713-792-2830    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer

Investigators
Principal Investigator:     Paul Mathew, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Paul Mathew, MD/Assistant Professor )
Study ID Numbers:   2006-0684
First Received:   February 27, 2008
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00631527
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer  
Radiation Therapy  
Hormone Ablation  
Sunitinib Malate  
Leuprolide  
Lupron  
Zoladex
Goserelin
Casodex
Bicalutamide
SU011248
Sutent

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Sunitinib
Goserelin
Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Growth Substances
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 31, 2008




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