A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
Hematopoietic:
- ANC > 1500/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 9 g/dL
Hepatic:
- 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.
Renal:
- Calculated creatinine clearance >45 mL/min based on the standard Cockroft and Gault
formula
Cardiovascular:
- 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
therapy
- Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal
supraventricular tachycardia, or controlled hypertension are eligible
Pulmonary:
- Not specified
Inclusion Criteria:
- Histologically documented adenocarcinoma of the prostate
- Clinically refractory or resistant to hormone therapy as assessed by progression
following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing
hormone (LHRH) agonist)
- One prior taxane based chemotherapy regimen for HRPC
- Documented progression of disease after one taxane based prior chemotherapy regimen
for HRPC. Progression is defined as at least one of the following:
- An increase in PSA > 50% over nadir value on prior Taxane-based therapy
- Progression of measurable disease as defined by RECIST
- Progression of bone disease as defined by the appearance of one or more new bone
lesions or worsening symptoms
- Orchiectomy or testosterone levels < 50 ng/dL maintained by LHRH agonist
- Prior chemotherapy, or other experimental anticancer agents must be completed > 4
weeks prior to being registered for protocol therapy
- Palliative radiotherapy must be completed at least 14 days prior to registration.
Exclusion Criteria:
- Intravenous radio-isotopes therapy must be completed at least 6 weeks prior to
registration
- No brain metastasis that are untreated and/or not controlled and/or still requiring
corticosteroids
- No history of other malignancies within 5 years prior to being registered for
protocol therapy, except for adequately treated basal or squamous cell skin cancer
- No history of uncontrolled psychiatric illness or serious systemic disease, including
active infection, uncontrolled hypertension
- No surgery or significant traumatic injury within 21 days prior to being registered
for protocol therapy
- Patients must be willing to interrupt aspirin or other non-steroidal
anti-inflammatory agents for a 5-day period (8 day period for long acting agents such
as piroxicam)
- Patients must be willing to take folic acid or vitamin B12 supplementation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
· 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·
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Christopher Sweeney, M.B.B.S.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, LLC
Authority:
United States: Institutional Review Board
Study ID:
HOG GU03-67
NCT ID:
NCT00216099
Start Date:
February 2005
Completion Date:
March 2009
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| 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 |
