Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy
- Registration Number
- NCT00589420
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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 regimen.
* To measure the percentage of patients surviving at 2 years.
* To determine the toxicities and estimate toxicity rates for patients treated with this regimen.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase II docetaxel All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks Phase II sorafenib tosylate All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks
- Primary Outcome Measures
Name Time Method Prostate Specific Antigen (PSA) Response Rate From start of treatment until withdrawal from the study, approximately 12 months PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression.
PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 6 months from end of treatment To determine the ORR in patients with measurable disease
6-month Progression-free Survival (PFS) 6 months from end of treatment Number of patients that achieved 6 month PFS
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States