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Study of Aranesp to Treat Anemia in Prostate Cancer Patients. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Aranesp to Treat Anemia in Prostate Cancer Patients.

Phase II Study of Aranesp (Darbepoetin Alfa) to Treat Anemia in Prostate Cancer Patients.

NCT00245895•University of Washington

Summary

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.

Detailed Description

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

Age

All ages

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must have either histologically confirmed adenocarcinoma of the prostate or clinical evidence including a PSA greater than 50, with evidence of bone metastases, currently receiving either androgen suppression or chemotherapy.
•Patients on concurrent androgen deprivation treatment that consists of either orchiectomy or a GnRH agonist (Zoladex or Lupron) with or without and androgen receptor antagonist (Casodex, Nilandron, or Eulexin) therapy, as long as therapy was initiated within the last 3 months. Finasteride treatment must be discontinued. Secondary hormonal therapy with DES or ketoconazole is permitted.
•Patients may have a history of radiation therapy, providing that at least 6 weeks have elapsed from the last treatment date to study day 1.
•Patients must have a life expectancy of at least 12 months and a zubrod performance status of 0-2.
•Patients must not have evidence of hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery.
•Patients must have serum creatinine level of less than or equal to 2 mg/dL.
•Patients must have adequate liver function, as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2 x ULN within the 3 months prior to screening.
•Before any study-specific procedure, the patients must give written informed consent to participate in the study.

Exclusion Criteria

•Patients presenting an active primary or metastatic malignancy involving the CNS. Patients with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study, if they have had no clinical signs or symptoms of, not treatment for CNS disease, and no history of seizures within the previous 2 years.
•Patients receiving rHuEPO therapy within 4 weeks prior to first dose of the study drug.
•Active bleeding or RBC transfusion within 4 weeks prior to fist dose of study drug.
•Patients with an active seizure disorder. Patients with a previous history of seizure disorder will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of anti-convulsant medication for the previous 5 years.
•Patients with uncontrolled angina, congestive heart failure or uncontrolled cardiac arrhythmia.
•Patients with uncontrolled hypertension
•Patients with a history of hyperviscosity syndrome
•Patients with evidence of clinically significant systemic active infection or inflammatory disease
•Patients with known positive test for human immunodeficiency virus (HIV) infection
•Patients with inadequate iron stores (Fe/TIBC less than 15% and ferritin less than 10.0 mg/L)
+4 more criteria

Locations (2)

Oregon Health and Sciences University

Portland, Oregon, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

April 1, 2003

Completion Date

February 1, 2005

Last Updated

November 29, 2007

Enrollment

ACTUAL participants

Conditions

Prostate CancerAnemia

Interventions

Aranesp

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Aranesp to Treat Anemia in Prostate Cancer Patients.

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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