Hormone Refractory, Prostate Cancer
Conditions
Keywords
Sutent
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.
Interventions
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
Sponsors
Pfizer
Alberta Health services
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 180 days without evidence of disease progression would be considered clinically worthy of further investigation |
Secondary
| Measure | Time frame |
|---|---|
| -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. |
Countries
Canada
Outcome results
None listed