At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate adenocarcinoma
- ✓Hormone-refractory disease after at least one prior hormonal therapy (orchiectomy or LHRH agonist)
- ✓One prior taxane-based chemotherapy regimen for HRPC
- ✓Documented progression after taxane therapy: PSA >50% increase from nadir, RECIST measurable disease progression, or new bone lesions/worsening symptoms
- ✕Untreated, uncontrolled, or corticosteroid-requiring brain metastases
- ✕Other malignancies within 5 years (except adequately treated basal or squamous cell skin cancer)
- ✕Uncontrolled psychiatric illness or serious systemic disease (active infection, uncontrolled hypertension)
- ✕Surgery or significant traumatic injury within 21 days before registration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67
In Brief
A Phase 2 clinical trial evaluating Pemetrexed, Folic Acid, and 1 other intervention for Prostate Cancer. Completed, enrolled 49 participants across 15 sites.
Detailed 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.
Study Details
Timeline
Interventions
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed.
All patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.