A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer
- To determine the proportion of patients achieving a 50% reduction in serum PSA from
baseline in patients with androgen-independent prostate cancer (AIPC) receiving
sorafenib tosylate and docetaxel.
- To estimate the progression-free survival of patients with AIPC.
- To quantify the number and percent of patients who have stable disease at 6 months of
therapy (failure to progress).
- To estimate median time to progression for all patients.
- To estimate the objective response rate of patients with AIPC treated with this
- To measure the percentage of patients surviving at 2 years.
- To determine the toxicities and estimate toxicity rates for patients treated with this
- To measure changes in tumor vasculature in response to therapy in selected patients
with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary
objectives to these measurement changes.
- To measure changes in serum HMGB1 in response to therapy and correlate primary and
secondary objectives with these changes.
- To measure changes in serum cathepsin D in response to therapy and correlate primary
and secondary objectives with these changes.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV
on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral
sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in
the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels
before and after therapy.
Masking: Open Label, Primary Purpose: Treatment
PSA response rate
Amy Kramer, RN, MPA
Abramson Cancer Center of the University of Pennsylvania
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|