Status:
COMPLETED
Impact of Erythropoietin Treatment Versus Placebo on Quality-of-life in Patients With Advanced Prostate Cancer.
Lead Sponsor:
Janssen-Ortho Inc., Canada
Collaborating Sponsors:
Ontario Clinical Oncology Group (OCOG)
Conditions:
Prostate
Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) or placebo on anemia related quality-of-life and anemia in hormone-refractory (no...
Detailed Description
Anemia is a common problem experienced by patients with malignancy. Although cancer treatment such as systemic chemotherapy is an obvious cause, many cancer patients are anemic at presentation. Estima...
Eligibility Criteria
Inclusion
- Patients with histological confirmed adenocarcinoma of the prostate or patients who have metastatic carcinoma of presumptive prostate origin as manifest by the presence of sclerotic bony metastases and a serum PSA level greater than the upper limit of normal
- Hemoglobin level at or below 120 g/L
- ECOG (Eastern Cooperative Oncology Group) Performance status of 0-2.
Exclusion
- No known or suspected CNS metastasis (Cancer that has spread from the original (primary) tumor to the central nervous system)
- No other active concurrent malignancy, other than the underlying prostate cancer which is expected to influence QoL
- No blood transfusions within the last 14 days and no previous use of erythropoietin (i.e., that would impact baseline Hb)
- No anemia due to factors other than cancer/radiotherapy (i.e., hemolysis or gastrointestinal bleeding, evidence of untreated folate or vitamin B12 deficiency)
- No history of uncontrolled hypertension or diastolic blood pressure greater than 100 mmHg
- No mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of quality-of-life questionnaires.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00364455
Start Date
December 1 2002
End Date
March 1 2006
Last Update
April 27 2010
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