Sutent Maintenance After Response to Taxotere

Phase 2

• Conditions: Hormone Refractory; Prostate Cancer

• Registration Number: NCT00550810
• Lead Sponsor: Alberta Health services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Status Verified: 2011-09
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	180 days without evidence of disease progression would be considered clinically worthy of further investigation

Secondary Outcome Measures

Name	Time	Method
-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.

Trial Locations

Locations (4)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada