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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00790595
First received: November 12, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: SU011248
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: June 2006
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
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 1 week.
Experimental: Group B
5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
Drug: SU011248
5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
Experimental: Group C
5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
Drug: SU011248
5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
Experimental: Group D
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 2 weeks.
Experimental: Group E
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 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790595

Locations
United States, California
University of California, Los Angeles, Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Pfizer
Investigators
Principal Investigator: Arie Belldegrun, M.D. University of California, Los Angeles
  More Information

Publications:
Stamey TA and McNeal JE: Adenocarcinoma of the prostate. In Campbell's Urology 6th edition (Walsh PC, Retik AB, Stamey MA and Vaughan ED, eds), W.B. Saunders Co., pp 1159-1221, 1992.

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00790595     History of Changes
Other Study ID Numbers: 06-03-129, Pfizer2005-0958
Study First Received: November 12, 2008
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
Prostatectomy

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

ClinicalTrials.gov processed this record on September 18, 2014