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

NCT00790595 | Completed Phase 1 DMC

• 2 other identifiers: 06-03-129Pfizer2005-0958
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostatectomy

Outcome Measures

Primary Outcomes (2)

• To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.

  24 months

• To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy.

  4 weeks

Secondary Outcomes (1)

• To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels.

  4 weeks

Study Arms (5)

Group A

EXPERIMENTAL

5 Subjects will receive 37.5 mg/d of the study drug for 1 week.

Drug: SU011248

Group B

EXPERIMENTAL

5 Subjects will receive 50.0 mg/d of the study drug for 1 week.

Drug: SU011248

Group C

EXPERIMENTAL

5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.

Drug: SU011248

Group D

EXPERIMENTAL

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

Drug: SU011248

Group E

EXPERIMENTAL

5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.

Drug: SU011248

Interventions

SU011248 DRUG

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

Group D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of California, Los Angeles, Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (19)

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  PMID: 12953083 BACKGROUND

• Cancer Facts and Figures 2004. American Cancer Society, 2004.

  BACKGROUND

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  PMID: 10235151 BACKGROUND

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  PMID: 2219577 BACKGROUND

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  PMID: 8490929 BACKGROUND

• Cumming JA, Ritchie AW, Goodman CM, McIntyre MA, Chisholm GD. De-differentiation with time in prostate cancer and the influence of treatment on the course of the disease. Br J Urol. 1990 Mar;65(3):271-4. doi: 10.1111/j.1464-410x.1990.tb14725.x.

  PMID: 2337747 BACKGROUND

• 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.

  BACKGROUND

• Stamey TA, Villers AA, McNeal JE, Link PC, Freiha FS. Positive surgical margins at radical prostatectomy: importance of the apical dissection. J Urol. 1990 Jun;143(6):1166-72; discussion 1172-3. doi: 10.1016/s0022-5347(17)40216-3.

  PMID: 2342177 BACKGROUND

• Rosen MA, Goldstone L, Lapin S, Wheeler T, Scardino PT. Frequency and location of extracapsular extension and positive surgical margins in radical prostatectomy specimens. J Urol. 1992 Aug;148(2 Pt 1):331-7. doi: 10.1016/s0022-5347(17)36587-4.

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  PMID: 2304166 BACKGROUND

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• Frazier HA, Robertson JE, Humphrey PA, Paulson DF. Is prostate specific antigen of clinical importance in evaluating outcome after radical prostatectomy. J Urol. 1993 Mar;149(3):516-8. doi: 10.1016/s0022-5347(17)36132-3.

  PMID: 7679755 BACKGROUND

• R Motzer, B Rini, M Michaelson, B Redman, G Hudes, G Wilding, R Bukowski, D George, S Kim, I Chen, C Baum and the SU11248 Study Group: Phase 2 Trials of SU11248 Show Antitumor Activity in Second-Line Therapy for Patients with Metastatic Renal Cell Carcinoma (RCC). ASCO, 2005.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arie Belldegrun, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2009
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)