Study of SU11248 in Men With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00299741
First received: March 3, 2006
Last updated: December 14, 2012
Last verified: December 2012
  Purpose
  • 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:

    1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
    2. 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:

    1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
    2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

Condition Intervention Phase
Prostate Cancer
Drug: Sunitinib
Phase 2

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: A Phase II Study of SU011248 in Men With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response [ Time Frame: were followed until disease progression, an average of 12 weeks ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Objective Responses, Defined as the Number of Participants With Complete or Partial Response [ Time Frame: Participants were followed until the time of disease progression, an average of 12 weeks ] [ Designated as safety issue: No ]
    The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.


Enrollment: 36
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sunitinib
Drug: Sunitinib
Sunitinib 50 mg daily, 4/2 schedule
Other Name: Sutent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Prostate Specific Antigen (PSA) > 5.0 ng/mL, based on PSA Working Group Criteria
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

For Group A only:

· No prior treatment for prostate cancer with cytotoxic chemotherapy

For Group B only:

  • Radiographic evidence of metastatic prostate cancer
  • One prior docetaxel-based chemotherapy regimen, minimum of two cycles
  • Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel

Exclusion Criteria:

  • 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.
  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: NCT00299741

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Dror Michaelson, MD PhD Massachusetts General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dror Michaelson, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00299741     History of Changes
Other Study ID Numbers: W81XWH-05-1-0439
Study First Received: March 3, 2006
Results First Received: May 9, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Sutent
Sunitinib
Bone
Metastatic
Hormone-refractory
Biomarkers

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