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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
Amgen |
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00245895 |
Purpose
The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate cancer patients have low red blood cell counts (low hemoglobin) from various treatments they are receiving, such as chemotherapy. The red blood cells deliver oxygen to the tissue. This then helps give the patient more energy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Anemia |
Drug: Aranesp |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II Study of Aranesp (Darbepoetin Alfa) to Treat Anemia in Prostate Cancer Patients. |
| Enrollment: | 20 |
| Study Start Date: | April 2003 |
| Study Completion Date: | February 2005 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Aranesp
|
Drug: Aranesp
Aranesp
|
This study is to evaluate the effectiveness of Darbepoetin alfa, (also referred to as Aranesp or NESP), to assess what dose of NESP is required to treat anemia in prostate cancer patients, what the side effects of NESP are, and whether NESP will affect the patients' quality of life. NESP is approved by the FDA for the treatment of anemia in patients with chronic kidney failure and for the treatment of anemia in cancer patients who are receiving chemotherapy. It is considered experimental for the treatment of anemia in prostate cancer patients.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |
| Oregon Health and Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Celestia S Higano, MD | University of Washington |
| Principal Investigator: | Tomasz M Beer, MD | Oregon Health and Science University |
More Information
| Study ID Numbers: | 03-6503-A |
| Study First Received: | October 26, 2005 |
| Last Updated: | November 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00245895 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anemia, Prostate Cancer |
|
Genital Neoplasms, Male Prostatic Diseases Hematologic Diseases Hematinics Hematologic Agents Anemia Darbepoetin alfa |
Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |