Status:
COMPLETED
Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
Lead Sponsor:
Christopher Sweeney, MBBS
Collaborating Sponsors:
Eli Lilly and Company
Walther Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 effect...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00216099
Start Date
February 1 2005
End Date
March 1 2009
Last Update
July 29 2016
Active Locations (15)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Elkhart Clinic
Elkhart, Indiana, United States, 46515
3
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202