Status:
COMPLETED
A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Amgen
Conditions:
Anemia
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved functional status ...
Detailed Description
Anemia associated with lung cancer and chemotherapy is an important factor effecting patient symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer, Choy et al. 2002)...
Eligibility Criteria
Inclusion
- Confirmation of non-myeloid cancer (myeloproliferative disorders will be excluded).
- Hemoglobin concentration ≤ 11.0 g/dL.
- Age ≥ 18 years.
- Karnofsky performance status ≥ 60%.
- Anemia predominantly due to cancer or chemotherapy.
- Serum creatinine concentration ≤ 2.0 mg/dL.
- Total serum bilirubin ≤ 1.5 times the upper limit of normal.
- Nutritional status adequate to provide vitamin B12 and folate within the normal limits.
- Capacity to complete the web-based functional status, symptom and quality of life assessments.
- Ability to give informed consent.
Exclusion
- Untreated symptomatic primary or metastatic cancer involving the central nervous system.
- History of clinically significant iron deficiency.
- Greater than two red blood cell transfusions within 2 weeks of registration or any red blood cell transfusion within 7 days of registration.
- Received epoetin alfa or darbepoetin alfa therapy within 3 weeks prior to randomization.
- History of a seizure disorder.
- Unstable angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%) or uncontrolled cardiac arrhythmias.
- Uncontrolled hypertension defined as a diastolic blood pressure \> 100 mmHg.
- Clinical evidence of active infection or inflammatory diseases such as rheumatoid arthritis. Subjects with active rheumatoid arthritis are excluded.
- Known positive test for human immunodeficiency virus infection.
- Known primary hematological disorder which could cause anemia such as sickle cell anemia.
- Pregnant or breast-feeding.
- Not using adequate contraception if of childbearing potential.
- Known hypersensitivity to any recombinant mammalian-derived product.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00153868
Start Date
October 1 2003
End Date
August 17 2007
Last Update
September 23 2021
Active Locations (1)
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1
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756