Sutent Maintenance After Response to Taxotere (SMART)

Alberta Health services

Status and phase: Unknown; Phase 2

Conditions: Hormone Refractory; Prostate Cancer

Treatments: Drug: Sunitinib (SU011248)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00550810

SMART

TBCC-0707001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)