Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
Public ClinicalTrials.gov record NCT00216099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00216099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
- Pemetrexed Drug
- Folic Acid Dietary Supplement
- Vitamin B12 Dietary Supplement
Drug · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2005
- Primary completion
- Feb 28, 2009
- Completion
- Feb 28, 2009
- Last update posted
- Jul 28, 2016
2005 – 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 6
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | — |
| Elkhart Clinic | Elkhart | Indiana | 46515 | — |
| Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana | 46815 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | — |
| Community Regional Cancer Center | Indianapolis | Indiana | 46256 | — |
| Arnett Cancer Care | Lafayette | Indiana | 47904 | — |
| Medical Consultants, P.C. | Muncie | Indiana | 47303 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| AP&S Clinic | Terre Haute | Indiana | 47804 | — |
| Center for Hematology/Oncology of S. Michigan | Jackson | Michigan | 49201 | — |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | — |
| Hematology Oncology Associates S.J., P.A. | Mount Holly | New Jersey | 08060 | — |
| Consultants in Medical Oncology & Hematology | Drexel Hill | Pennsylvania | 19026 | — |
| Pennsylvania Oncology-Hematology Associates | Philadelphia | Pennsylvania | 19106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00216099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2016 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00216099 live on ClinicalTrials.gov.