Back to resultsSutent Maintenance After Response to Taxotere (SMART)
Primary Purpose
Prostate Cancer, Hormone Refractory
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sunitinib (SU011248)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Sutent
Eligibility 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.
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Vancouver Cancer Centre
- London Health Sciences Centre
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
-PSA Response -Toxicity
Full Information
NCT ID
NCT00550810
First Posted
October 26, 2007
Last Updated
December 6, 2011
Sponsor
Alberta Health services
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00550810
Brief Title
Sutent Maintenance After Response to Taxotere
Acronym
SMART
Official Title
A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Health services
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Hormone Refractory
Keywords
Sutent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sunitinib (SU011248)
Other Intervention Name(s)
Sutent
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
180 days without evidence of disease progression would be considered clinically worthy of further investigation
Secondary Outcome Measure Information:
Title
-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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Eigl, M.D.
Organizational Affiliation
Tom Baker Cancer Board
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
t4c 2h5
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
12. IPD Sharing Statement
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Sutent Maintenance After Response to Taxotere
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