A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67
OUTLINE: This is a multi-center study.
- Pemetrexed 500mg/m2 will be administered intravenously over approximately 10-minutes on
Day 1 of a 21-day cycle.
- Folic Acid (350-1000 mcg. PO daily) will be taken by patients to reduce toxicity. At
least 5 daily doses of folic acid must be taken during the 7-day period preceding the
first dose of pemetrexed, and dosing should continue during the full course of therapy
and for 21 days after the last dose of pemetrexed.
- Vitamin B12 (1000 µg) will be administered as an intramuscular injection during the
week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent
vitamin B12 injections may be given the same day as pemetrexed.
Performance Status: Karnofsky Performance Status 70-100
Life expectancy > 12 weeks
- ANC > 1500/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 9 g/dL
- Bilirubin < 1.5 X upper limit of normal (unless due to Gilbert's disease)
- Alkaline phosphatase and ALT (SGPT) < 3 X upper limit of normal; may be < 5 X ULN for
patients with liver metastases. Alkaline phosphatase may be any value for patients
with bone metastases.
- Calculated creatinine clearance >45 mL/min based on the standard Cockroft and Gault
- No congestive heart failure requiring therapy or NYHA class II or greater or active
angina or known myocardial infarction within 12 months prior to study
- No unstable angina, uncontrolled congestive heart failure, or unstable symptomatic
arrhythmia requiring medication within 6 months prior to being registered for protocol
- Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal
supraventricular tachycardia, or controlled hypertension are eligible
- Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
· To determine the rates of best overall PSA response (≥ 50% decline in PSA) at any time during the study with single agent pemetrexed in subjects with HRPC whose disease has progressed following one prior taxane based chemotherapy regimen for HRPC·
Christopher Sweeney, M.B.B.S.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Methodist Cancer Center||Omaha, Nebraska 68114|
|Arnett Cancer Care||Lafayette, Indiana 47904|
|Consultants in Medical Oncology & Hematology||Drexel Hill, Pennsylvania 19026|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Elkhart Clinic||Elkhart, Indiana 46515|
|Community Regional Cancer Center||Indianapolis, Indiana 46256|
|Quality Cancer Center (MCGOP)||Indianapolis, Indiana 46202|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|AP&S Clinic||Terre Haute, Indiana 47804|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|
|Center for Hematology/Oncology of S. Michigan||Jackson, Michigan 49201|
|Hematology Oncology Associates S.J., P.A.||Mt. Holly, New Jersey 08060|
|Pennsylvania Oncology-Hematology Associates||Philadelphia, Pennsylvania 19106|