SMART: Sutent Maintenance After Response to Taxotere

• Sponsor: Alberta Health services (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00550810
• Collaborator: Pfizer (Industry)
• Enrollment: 30
• Locations: 4
• Duration (Months): 61
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Hormone Refractory	Drug: Sunitinib (SU011248)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
• Study Start Date: Oct 1, 2007
• Anticipated Study Completion Date: Nov 1, 2012

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [180 days without evidence of disease progression would be considered clinically worthy of further investigation]

Secondary Outcome Measures

1. -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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Centre	Calgary	Alberta	Canada	t4c 2h5
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
4	London Health Sciences Centre	London	Ontario	Canada	N6A 4L6

Sponsors and Collaborators

• Alberta Health services
• Pfizer

Investigators

• Study Chair: Bernhard Eigl, M.D., Tom Baker Cancer Board

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rachel Syme, Dr. Bernie Eigl, Alberta Health services
• ClinicalTrials.gov Identifier: NCT00550810
• Other Study ID Numbers: TBCC-0707001; SMART
• First Posted: Oct 30, 2007
• Last Update Posted: Dec 7, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Rachel Syme, Dr. Bernie Eigl, Alberta Health services: Sutent
• Additional relevant MeSH terms: Prostatic Neoplasms; Sunitinib

Study Results

No Results Posted as of Dec 7, 2011