Sutent Maintenance After Response to Taxotere
This trial is active, not recruiting.
|Conditions||prostate cancer, hormone refractory|
|Sponsor||AHS Cancer Control Alberta|
|Start date||October 2007|
|End date||November 2012|
|Trial size||30 participants|
|Trial identifier||NCT00550810, SMART, TBCC-0707001|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Calgary, Canada||Tom Baker Cancer Centre||no longer recruiting|
|Edmonton, Canada||Cross Cancer Institute||no longer recruiting|
|Vancouver, Canada||Vancouver Cancer Centre||no longer recruiting|
|London, Canada||London Health Sciences Centre||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Progression Free Survival
time frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation
-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.
Male participants at least 18 years old.
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.
|Official title||A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy|
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