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

NCT00153868 | Completed Phase 4 FDA Drug

• 1 other identifier: D-0341
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Cancer

Keywords

Anemia; Cancer; Quality of life; Web-based; Aranesp; Darbepoetin alfa

Outcome Measures

Primary Outcomes (1)

• A secure web-based assessment of cancer-related symptoms (LCSS), functional status (SF-36), and quality of life (FACT-An and PFS) will be obtained every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).

  every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)

Secondary Outcomes (2)

• A blood sample will be obtained to evaluate hemoglobin concentrations every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).

  every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)

• A blood sample will be obtained to evaluate plasma cytokines every 4 weeks (weeks 5, 9, and 13).

  every 4 weeks (weeks 5, 9, and 13)

Study Arms (2)

1

ACTIVE COMPARATOR

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)

Biological: darbepoetin alfa

2

ACTIVE COMPARATOR

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)

Biological: darbepoetin alfa

Interventions

darbepoetin alfa 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.

Also known as: aranesp

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Amgen: collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• James R Rigas, MD

  Norris Cotton Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2003
• Primary Completion: August 17, 2007
• Study Completion: August 17, 2007
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

US (1)