Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

NCT00672594

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer, Prostatectomy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP

- Intermediate or high risk, clinically localized disease

- Adequate organ function

- Patients must be surgically sterile or must agree to use effective contraception during the period of therapy

- Select imaging to rule out metastasis will be done as clinically indicated

- Signed and date informed consent document

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment for prostate cancer


- Major surgery or radiation therapy within 4 weeks of starting the study treatment


- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy


- History of or known metastatic prostate cancer


- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.


- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater


- QTc interval > 500 msec on baseline EKG


- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
medical therapy).


- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication


- Known active infection


- Concurrent treatment on another clinical trial. Supportive care trials or
non-treatment trials, e.g. QOL, are allowed.


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in
the judgment of the investigator would make the subject inappropriate for entry into
this study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate Cancer, ProstatectomyStudy of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
NCT00672594
  1. Durham, North Carolina
  2. Houston, Texas
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Official Title  ICMJE Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Brief Summary The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.
Detailed Description Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostatectomy
Intervention  ICMJE Drug: Sunitinib Malate
Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
Other Name: Sutent
Study Arms  ICMJE Experimental: Sunitinib Malate
Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
Intervention: Drug: Sunitinib Malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
  • Intermediate or high risk, clinically localized disease
  • Adequate organ function
  • Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
  • Select imaging to rule out metastasis will be done as clinically indicated
  • Signed and date informed consent document

Exclusion Criteria:

  • Prior treatment for prostate cancer
  • Major surgery or radiation therapy within 4 weeks of starting the study treatment
  • NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
  • History of or known metastatic prostate cancer
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
  • QTc interval > 500 msec on baseline EKG
  • Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Known active infection
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00672594
Other Study ID Numbers  ICMJE Pro00007396
DUMC-8725 ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Daniel J George, MDDuke University
PRS Account Duke University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP