Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00329043
First received: May 19, 2006
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The goal of this clinical research study is to learn if the addition of sunitinib malate (SU011248) to hormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed.


Condition Intervention Phase
Prostate Cancer
Drug: LHRH Agonist
Drug: Sunitinib Malate
Procedure: Radical Prostatectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Neoadjuvant Trial of Sunitinib Malate (SU011248) Plus Hormonal Ablation for Patients Who Have High Risk Localized Prostate Cancer and Will Undergo Prostatectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Pathological Complete Response (pCR) [ Time Frame: Surgery following 3 months of therapy. ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: May 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib + Hormonal Ablation Before Prostatectomy
Sunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist.
Drug: LHRH Agonist
Intramuscular injection either monthly for 3 months or in a single 3-month dose.
Other Names:
  • Lupron
  • Leuprolide
Drug: Sunitinib Malate
25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
Other Name: SU011248
Procedure: Radical Prostatectomy
Radical prostatectomy after completion of Sunitinib and LHRH agonist.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
  2. All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
  3. All patients must have one of the following high-risk features: clinical (c) T(subscript)3 disease or Gleason 8-10 adenocarcinoma or cT(subscript)2(subscript)b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
  4. ECOG performance status 0 or 1.
  5. Prior hormonal therapy up to 2 months is permitted.
  6. Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1,500/mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g/dl; adequate hepatic function defined as a total bilirubin of <=1.5 mg/dl and AST/ALT <= 2 x the upper limit of normal; adequate renal function defined as serum creatinine <= 1.5 x the upper limits of normal or creatinine clearance >= 40cc/min (measured or calculated).
  7. Patients must sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
  8. All patients must have a surgical and medical oncology consult prior to signing informed consent.

Exclusion Criteria:

  1. Patients with small cell or sarcomatoid prostate cancers are not eligible.
  2. Patients with clinical or radiological evidence of metastatic disease.
  3. Patients receiving ketoconazole as a prior hormonal therapy.
  4. Prior chemotherapy or experimental agents for prostate cancer.
  5. Patients with any infection process, in the criterion of the investigator, that could worsen or its outcome be affected, as a result of the investigational therapy.
  6. Patients with NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident or transient ischemic attack, or pulmonary embolism or myocardial infarction in the last 6 months.
  7. Uncontrolled severe hypertension (>= 140/90 despite controlling medication), uncontrolled diabetes mellitus, oxygen-dependent lung disease, known chronic liver disease or HIV infection.
  8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
  9. Ongoing treatment with therapeutic doses of coumadin. However, low dose coumadin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed. Low molecular weight heparin is allowed.
  10. Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329043

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Principal Investigator: Amado Zurita, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00329043     History of Changes
Other Study ID Numbers: 2005-0903
Study First Received: May 19, 2006
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Adenocarcinoma of the Prostate
Ductal Adenocarcinoma of the Prostate
Hormonal Ablation
Radical Prostatectomy
LHRH Agonist
Lupron
Leuprolide
Sunitinib Malate
SU011248

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Sunitinib
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014