A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer

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). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon
ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002;
Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association
between the treatment of anemia with darbepoetin alfa and direct electronic capture of
clinical benefits in cancer-related symptoms, functional status and overall quality of life.
This trial uses a secure web-based design to capture the patient-associated symptoms,
functional status and quality of life. This novel secure web-based system was selected to
improve the efficiency and quality of clinical data capture. If our hypothesis is correct,
treatment with darbepoetin alfa will be associated with improved palliation of cancer-related
symptoms, improved functional status, and result in overall benefits to the patient's
health-related quality of life. The development of a web-based system to directly capture
patient-related symptoms, functional status and quality of life will permit us in the future
to conduct a national or international trial addressing the effects of darbepoetin alfa on
these factors. If our hypothesis is incorrect, it may be that these parameters are not
affected by the correction of anemia with darbepoetin alfa or the measures are not sensitive
enough to detect these differences. A notable finding would be a clearly defined improvement
in symptom palliation, functional status, and quality of life associated with darbepoetin
alfa therapy.

Inclusion Criteria:

- 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 Criteria:

- 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.