Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Christopher Sweeney, MBBS
Collaborators:
Eli Lilly and Company Walther Cancer Institute
Treatments:
Folic Acid Hormones Hydroxocobalamin Pemetrexed Vitamin B 12 Vitamin B Complex Vitamins