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Sutent Maintenance After Response to Taxotere (SMART)

This study is currently recruiting participants.
Verified by Alberta Cancer Board, August 2008

Sponsors and Collaborators: Alberta Cancer Board
Pfizer
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00550810
  Purpose

The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.

Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.


Condition Intervention Phase
Prostate Cancer
Hormone Refractory
Drug: Sunitinib (SU011248)
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Docetaxel    Sunitinib    Sunitinib malate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation ]

Secondary Outcome Measures:
  • -PSA Response -Toxicity [ Time Frame: The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise. ]

Estimated Enrollment:   30
Study Start Date:   October 2007
Estimated Study Completion Date:   November 2009

Intervention Details:
    Drug: Sunitinib (SU011248)
    SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic or locally recurrent disease not curable with standard therapy
  • ECOG performance status 0, 1 or 2
  • Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment

Exclusion Criteria:

  • Patients with a history of other invasive cancer, except adequately treated non
  • melanoma skin cancer.
  • Patients with known brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248.
  • Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550810

Contacts
Contact: Christine Lazzer, MPH, BSc     403-521-3678     chlazzer@cancerboard.ab.ca    

Locations
Canada, Alberta
Cross Cancer Institute     Recruiting
      Edmonton, Alberta, Canada, T6G 1Z2
      Contact: Scott North, M.D.     780-432-8762     scottnor@cancerboard.ab.ca    
      Contact: Maureen Lesiuk     780-432-8349     maureenl@cancerboard.ab.ca    
      Principal Investigator: Scott North, M.D.            
Tom Baker Cancer Centre     Recruiting
      Calgary, Alberta, Canada, t4c 2h5
      Contact: Bernhard Eigl, M.D.     403-521-3347     bernieei@cancerboard.ab.ca    
      Contact: Christine Lazzer, MPH, BSc     403-521-3678     chlazzer@cancerboard.ab.ca    
      Principal Investigator: Bernhard Eigl, M.D.            
Canada, British Columbia
Vancouver Cancer Centre     Not yet recruiting
      Vancouver, British Columbia, Canada, V5Z 4E6
      Contact: Kim Chi, M.D.     604-877-6000     kchi@bccancer.bc.ca    
      Principal Investigator: Kim Chi, M.D.            
Canada, Ontario
London Health Sciences Centre     Not yet recruiting
      London, Ontario, Canada, N6A 4L6
      Contact: Eric Winquist, M.D.     519-685-8600     eric.winquist@lhsc.on.ca    

Sponsors and Collaborators
Alberta Cancer Board
Pfizer

Investigators
Study Chair:     Bernhard Eigl, M.D.     Tom Baker Cancer Board    
  More Information


Responsible Party:   Tom Baker Cancer Centre ( Dr. Bernhard Eigl )
Study ID Numbers:   TBCC-0707001, SMART
First Received:   October 26, 2007
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00550810
Health Authority:   Canada: Health Canada

Keywords provided by Alberta Cancer Board:
Sutent  

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Sunitinib
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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