Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

NCT00790595

Last updated date
Study Location
University of California, Los Angeles, Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed adenocarcinoma of the prostate glad.

- Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.

- Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.

- Patients must have elected to and are a candidate to undergo a radical prostatectomy.

- Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.

- Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.

- Performance status: ECOG < 2.

- Life expectancy of at least 5 years.

- Absolute granulocyte count > 1,500/mm3.

- Platelet count > 100,000.

- Hemoglobin > 9.0 g/dL.

- Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy.

- Creatinine < 1.5 ULN.

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


- Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.


- Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy,
biological response modifiers, or systematic chemotherapy to treat prostatic
carcinoma.


- Surgery within four weeks of study entry.


- Evidence of regional and/or distant metastases.


- Use of an investigational drug within 30 days prior to study entry.


- NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study
treatment.


- Any of the following thing the 12 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 Version 3.0 grade > 2.


- Prolonged QTc interval on baseline EKG.


- Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).


- Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit
juice or St. John's Wort while on the study


- Known active infection.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Official Title  ICMJE Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Brief Summary

Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself.

New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: SU011248
    5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
  • Drug: SU011248
    5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
  • Drug: SU011248
    5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
  • Drug: SU011248
    5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
  • Drug: SU011248
    5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
Study Arms  ICMJE
  • Experimental: Group A
    5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
    Intervention: Drug: SU011248
  • Experimental: Group B
    5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
    Intervention: Drug: SU011248
  • Experimental: Group C
    5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
    Intervention: Drug: SU011248
  • Experimental: Group D
    5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
    Intervention: Drug: SU011248
  • Experimental: Group E
    5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
    Intervention: Drug: SU011248
Publications *

*   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: April 20, 2011)
6
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
25
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate glad.
  • Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
  • Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
  • Patients must have elected to and are a candidate to undergo a radical prostatectomy.
  • Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
  • Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.
  • Performance status: ECOG < 2.
  • Life expectancy of at least 5 years.
  • Absolute granulocyte count > 1,500/mm3.
  • Platelet count > 100,000.
  • Hemoglobin > 9.0 g/dL.
  • Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy.
  • Creatinine < 1.5 ULN.

Exclusion Criteria:

  • Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
  • Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
  • Surgery within four weeks of study entry.
  • Evidence of regional and/or distant metastases.
  • Use of an investigational drug within 30 days prior to study entry.
  • NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
  • Any of the following thing the 12 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 Version 3.0 grade > 2.
  • Prolonged QTc interval on baseline EKG.
  • Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).
  • Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
  • Known active infection.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 75 Years   (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 NCT00790595
Other Study ID Numbers  ICMJE 06-03-129
Pfizer2005-0958
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Arie Belldegrun, M.D.University of California, Los Angeles
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2012

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