Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)
Overview
- Phase
- Phase 1
- Intervention
- Sorafenib
- Conditions
- Prostate Cancer
- Sponsor
- Oncology Specialists, S.C.
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Percentage of Patients Needing a Dose Reduction.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
Detailed Description
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.
Investigators
Dr. Sigrun Hallmeyer
Director of Research
Oncology Specialists, S.C.
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or
- •Patients with a known diagnosis of prostate cancer regardless of their Gleason grade.
- •Patients have AIPC.
- •Adequate bone marrow, liver and renal function as assessed by:
- •Hemoglobin \> 9.0 g/dl
- •absolute neutrophil count (ANC) \> 1,000/mm3
- •Platelet count \> 75,000/mm3
- •Total bilirubin \< 1.5 x upper limit of normal (ULN)
- •Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< 2.5 x the ULN (\< 5 x ULN for patients with liver involvement). international normalized ratio (INR) \< 1.5 or a Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
Exclusion Criteria
- •Cardiac disease: Congestive heart failure \> class II New York Heart Association 9NYHA). 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 \> Common Toxicity Criteria for Adverse Effects (CTCAE) Grade
- •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.
Arms & Interventions
Single agent Sorafenib
Oral Single agent Sorafenib 400mg twice daily
Intervention: Sorafenib
Outcomes
Primary Outcomes
Percentage of Patients Needing a Dose Reduction.
Time Frame: participants were followed for an average of 25 months
The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%
Secondary Outcomes
- Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).(3-10 months)
- PSA -Biochemical Response(1-10 months)