Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
Dr. Chadi Nabhan, Oncology Specialists, S.C.
First received: December 19, 2006
Last updated: December 7, 2012
Last verified: December 2012
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)
Primary Outcome Measures:
- The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy in patients with AIPC [ Time Frame: anytime during study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate the overall clinical benefit of this combination as calculated by the sum of complete response (CR), partial response (PR), and stable disease (SD). [ Time Frame: during study ] [ Designated as safety issue: No ]
- Evaluate toxicity of this combination therapy. Time to disease progression (TTP). [ Time Frame: during study ] [ Designated as safety issue: No ]
- PSA doubling time [ Time Frame: during study ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or uncontrolled coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414388
|Onocology Specialists, S.C
|Niles, Illinois, United States, 60714 |
|Oncology Specialists, S.C
|Park Ridge, Illinois, United States, 60068 |
Oncology Specialists, S.C.
||Chadi Nabhan, MD
||Oncology Specialists, SC
No publications provided
||Dr. Chadi Nabhan, Principal Investigator, Oncology Specialists, S.C.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2006
||December 7, 2012
||United States: Institutional Review Board
Keywords provided by Oncology Specialists, S.C.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action