Phase II Study of Aranesp (Darbepoetin Alfa) to Treat Anemia in Prostate Cancer Patients.
- 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.
- 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
- Patients receiving rHuEPO therapy within 4 weeks prior to first dose of the study
- 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
- Patients with uncontrolled hypertension
- Patients with a history of hyperviscosity syndrome
- Patients with evidence of clinically significant systemic active infection or
- 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
- Patients with a history or any primary hematologic disorder that could cause anemia
- Patients currently receiving, or not yet 30 days past receiving (prior to the first
dose of study drug), other investigational agents or devices not approved in any
indication by the governing regulatory authority. Note: an exception will be made
for patients receiving DN-101, a new formulation of calcitriol, on an investigational
- Patients who have previously received Aranesp (darbepoetin alfa) within 4 weeks prior
to fist dose of study drug.
- Patients with a known hypersensitivity to the active substance or any of the