Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00216099

Run by

Christopher Sweeney, MBBS

People needed

49

Starts

2005-02-01

Expected to finish

2009-03-01

Last updated by the study team

2016-07-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Quality Cancer Center (MCGOP) — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• Arnett Cancer Care — Lafayette, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• AP&S Clinic — Terre Haute, Indiana, United States
• Center for Hematology/Oncology of S. Michigan — Jackson, Michigan, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Hematology Oncology Associates S.J., P.A. — Mount Holly, New Jersey, United States
• Consultants in Medical Oncology & Hematology — Drexel Hill, Pennsylvania, United States
• Pennsylvania Oncology-Hematology Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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