Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)|
- Percentage of Patients Needing a Dose Reduction. [ Time Frame: participants were followed for an average of 25 months ] [ Designated as safety issue: Yes ]The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%
- Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD). [ Time Frame: 3-10 months ] [ Designated as safety issue: No ]Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.
- PSA -Biochemical Response [ Time Frame: 1-10 months ] [ Designated as safety issue: No ]PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.
|Study Start Date:||December 2006|
|Study Completion Date:||March 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Single agent Sorafenib
Oral Single agent Sorafenib 400mg twice daily
400mg twice daily
Other Name: Nexavar
Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414388
|United States, Illinois|
|Onocology Specialists, S.C|
|Niles, Illinois, United States, 60714|
|Oncology Specialists, S.C|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|