Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216099
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2005-09-12
Brief Title:
Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
Sponsor:
Christopher Sweeney MBBS
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Pemetrexed Alimta as Second-Line Therapy for Hormone Refractory Prostate Cancer Hoosier Oncology Group GU03-67
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer HRPC and has become the standard of care The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk when measurable reduction in prostate-specific antigen PSA reduction in symptoms particularly pain or stabilization of disease Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting
This trial is designed to further assess the efficacy safety tolerability and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC
This trial is designed to further assess the efficacy safety tolerability and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC
Detailed Description:
OUTLINE This is a multi-center study
Pemetrexed 500mgm2 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
Absolute Neutrophil Count ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 9 gdL
Hepatic
Bilirubin 15 X upper limit of normal unless due to Gilberts disease
Alkaline phosphatase and Alanine Transanimase ALT SGPT 3 X upper limit of normal ULN 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 mLmin based on the standard Cockroft and Gault formula
Cardiovascular
No congestive heart failure requiring therapy or New York Heart Association 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 ie atrial fibrillation paroxysmal supraventricular tachycardia or controlled hypertension are eligible
Pulmonary
Not specified
Pemetrexed 500mgm2 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
Absolute Neutrophil Count ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 9 gdL
Hepatic
Bilirubin 15 X upper limit of normal unless due to Gilberts disease
Alkaline phosphatase and Alanine Transanimase ALT SGPT 3 X upper limit of normal ULN 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 mLmin based on the standard Cockroft and Gault formula
Cardiovascular
No congestive heart failure requiring therapy or New York Heart Association 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 ie atrial fibrillation paroxysmal supraventricular tachycardia or controlled hypertension are eligible
Pulmonary
Not specified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None