Sutent Maintenance After Response to Taxotere

Prostate Cancer Clinical Trial

— SMART  

Official title:

A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00550810
• Other study ID #: TBCC-0707001
• Secondary ID: SMART
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 26, 2007
• Last updated: December 6, 2011
• Start date: October 2007
• Est. completion date: November 2012

Study information

• Verified date: September 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Vancouver Cancer Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		180 days without evidence of disease progression would be considered clinically worthy of further investigation
Secondary	-PSA Response -Toxicity		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.