Study of SU11248 in Men With Advanced Prostate Cancer

NCT00299741 | Completed Phase 2 Results

• 1 other identifier: W81XWH-05-1-0439
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

• There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
• SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
• SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
• This study is directed at two populations of men with advanced prostate cancer:
• Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
• Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
• Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
• to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
• to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

Conditions

Prostate Cancer

Keywords

Sutent; Sunitinib; Bone; Metastatic; Hormone-refractory; Biomarkers

Outcome Measures

Primary Outcomes (1)

• The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response

  Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)

  were followed until disease progression, an average of 12 weeks

Secondary Outcomes (1)

• Objective Responses, Defined as the Number of Participants With Complete or Partial Response

  Participants were followed until the time of disease progression, an average of 12 weeks

Study Arms (1)

1

EXPERIMENTAL

Sunitinib

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib 50 mg daily, 4/2 schedule

Also known as: Sutent

1

Eligibility Criteria

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

You may qualify if:

• Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
• Adenocarcinoma of the prostate
• Male subjects, 18 years of age or older
• Life expectancy of \> 12 weeks
• Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade \<1
• Surgical or ongoing chemical castration
• Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2
• Adequate bone marrow reserve:
• Neutrophil count \> 1,500/ul
• Platelet count \> 75,000/ul
• Adequate hepatic function:
• Serum bilirubin \< 1.5 x upper limit of normal
• Asparate aminotransferase and alanine aminotransferase \< 2.5 x upper limit of normal
• Adequate renal function, with serum creatinine \< 2 x upper limit of normal

You may not qualify if:

• Small cell carcinoma of the prostate
• Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
• Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
• Receipt of any investigational anti-cancer agent within 4 weeks of the study
• NCI CTCAE grade 3 hemorrhage \< 4 weeks of starting study treatment
• Uncontrolled hypertension
• Prolongation of the QTc interval to \> 450 msec
• Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Department of Defense: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel-Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Dror Michaelson M, Regan MM, Oh WK, Kaufman DS, Olivier K, Michaelson SZ, Spicer B, Gurski C, Kantoff PW, Smith MR. Phase II study of sunitinib in men with advanced prostate cancer. Ann Oncol. 2009 May;20(5):913-20. doi: 10.1093/annonc/mdp111.

  PMID: 19403935 RESULT

• Saylor PJ, Mahmood U, Kunawudhi A, Smith MR, Palmer EL, Michaelson MD. Multitargeted tyrosine kinase inhibition produces discordant changes between 99mTc-MDP bone scans and other disease biomarkers: analysis of a phase II study of sunitinib for metastatic castration-resistant prostate cancer. J Nucl Med. 2012 Nov;53(11):1670-5. doi: 10.2967/jnumed.112.105007. Epub 2012 Sep 14.

  PMID: 22984218 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Dror Michaelson
• Organization: Massachusetts General Hospital

dmichaelson1@partners.org

617-726-1594

Study Officials

• Dror Michaelson, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: March 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 19, 2012
• Results First Posted: December 13, 2012

Record last verified: 2012-12

Locations

US (3)