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

NCT ID: NCT00153868

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-08-17

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 and quality of life in patients with cancer. The feasibility of web-based assessments and data capture will be evaluated.

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). 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.

Conditions

Anemia; Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Darbepoetin alfa 200 mcg with escalation to 300 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11)

Group Type: ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type: BIOLOGICAL

The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience \<1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations \>13.0 g/dL.

2

darbepoetin alfa 300 mcg with escalation to 500 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 3 weeks for 12 weeks (weeks 1, 4, 7, and 10)

Group Type: ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type: BIOLOGICAL

The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience \<1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations \>13.0 g/dL.

Interventions

darbepoetin alfa

The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience \<1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations \>13.0 g/dL.

Intervention Type: BIOLOGICAL

Other Intervention Names

aranesp

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Konstantin Dragnev

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James R Rigas, MD

Role: PRINCIPAL_INVESTIGATOR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D-0341

Identifier Type: -

Identifier Source: org_study_id