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NCT00216099 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Christopher Sweeney, MBBS.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 15
- Study locations
NCT00216099: Completed Phase 2 study of Prostate Cancer, sponsored by Christopher Sweeney, MBBS.
NCT00216099 is a Phase 2 study of Prostate Cancer that has completed, run by Christopher Sweeney, MBBS. The registered enrollment target is 49 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216099, a Phase 2 study of Prostate Cancer, has completed, sponsored by Christopher Sweeney, MBBS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 15
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Pemetrexed
- DIETARY_SUPPLEMENT Vitamin B12
- DIETARY_SUPPLEMENT Folic Acid
Study Locations (15)
Indiana
- Elkhart Clinic - Elkhart
- Fort Wayne Oncology & Hematology, Inc - Fort Wayne
- Indiana University Cancer Center - Indianapolis
- Quality Cancer Center (MCGOP) - Indianapolis
- Community Regional Cancer Center - Indianapolis
- Arnett Cancer Care - Lafayette
- Medical Consultants, P.C. - Muncie
- Northern Indiana Cancer Research Consortium - South Bend
- AP&S Clinic - Terre Haute
Pennsylvania
- Consultants in Medical Oncology & Hematology - Drexel Hill
- Pennsylvania Oncology-Hematology Associates - Philadelphia
Illinois
- Medical & Surgical Specialists, LLC - Galesburg
Michigan
- Center for Hematology/Oncology of S. Michigan - Jackson
Nebraska
- Methodist Cancer Center - Omaha
New Jersey
- Hematology Oncology Associates S.J., P.A. - Mount Holly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216099
The ClinicalTrials.gov registry entry for NCT00216099 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Christopher Sweeney, MBBS, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pemetrexed is the first listed.
NCT00216099 reports 15 study locations spanning 6 distinct geographic areas - top geographies include Indiana, Pennsylvania, Illinois.
Frequently Asked Questions
What is clinical trial NCT00216099 about?
NCT00216099 is a clinical study titled "Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer". 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), reduc...
What is the current status of trial NCT00216099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-02. Estimated completion is 2009-03.
What conditions does trial NCT00216099 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00216099?
The interventions under investigation include: Pemetrexed (DRUG), Vitamin B12 (DIETARY_SUPPLEMENT), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00216099?
This trial is sponsored by Christopher Sweeney, MBBS, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00216099 being conducted?
This trial has 15 study locations across Illinois, Indiana, Michigan, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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