Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer
Purpose:
To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with
chemo-naïve hormone-refractory prostate cancer.
Hypothesis:
That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given
to patients with chemo-naïve hormone-refractory prostate cancer.
Justification:
The biologic and clinical activity and tolerability of BAY 43-9006, the therapeutic needs of
the proposed patient population, and the experimental evidence in support of targeting the
VEGF/VEGFR and MAPK pathways in combination with androgen receptor blockade in prostate
cancer, provides a strong rationale for the proposed phase II trial to evaluate the
tolerability and anti-cancer activity of combined treatment with the non-steroidal
anti-androgen bicalutamide with the multi-targeted kinase inhibitor BAY 43-9006 in patients
with prostate cancer that is progressing after castration therapy.
Objectives:
The primary study objective is to define the efficacy (i.e. post treatment decrement in PSA
(PSA response)) of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve
hormone-refractory prostate cancer.
Secondary Objectives:
- To determine the safety and tolerability of BAY 43-9006 given in combination with
bicalutamide in patients with HRPC.
- To determine the time to treatment failure, PSA progression and disease progression in
HRPC patients treated with BAY 43-9006 in combination with bicalutamide.
- To determine objective response rates in HRPC patients with measurable disease treated
with BAY 43-9006 in combination with bicalutamide.
Research Method:
This is a phase II clinical trial in patients with androgen independent prostate cancer
which will evaluate the therapeutic activity and safety profile of BAY 43-9006 given orally
at the recommended phase II dose of 400 mg PO BID continuously in combination with
bicalutamide 50 mg PO daily continuously. Each 4 week period will be considered 1 cycle.
Doses will be adjusted for toxicity.
Statistical Analysis:
Primary Endpoint The primary endpoint for this study will be the rate of PSA-response of the
combination for patients with rising PSA post castration therapy.
Secondary Endpoints:
Secondary endpoints will include time to treatment failure, time to PSA progression,
duration of PSA response, median survival time, 1 year survival rate, objective tumor
response rate and stable disease rate as defined by the RECIST criteria, response duration,
and incidence of toxicities by NCI CTCAE.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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