- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153868
A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer
September 17, 2021 updated by: Konstantin Dragnev, Dartmouth-Hitchcock Medical Center
Pilot Web-based Study of Functional Status, Symptom Palliation and Quality of Life Benefits Associated With Darbepoetin Alfa (Aranesp®) Administration in Anemic Patients With Cancer.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Norris Cotton Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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)
|
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.
Other Names:
|
Active Comparator: 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)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
Time Frame: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
|
every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A blood sample will be obtained to evaluate hemoglobin concentrations every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).
Time Frame: 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).
Time Frame: every 4 weeks (weeks 5, 9, and 13)
|
every 4 weeks (weeks 5, 9, and 13)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James R Rigas, MD, Norris Cotton Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
August 17, 2007
Study Completion (Actual)
August 17, 2007
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-0341
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on darbepoetin alfa
-
AmgenCompletedAnemia | Non-Myeloid Malignancies
-
University of New MexicoUniversity of UtahCompletedHypoxic-Ischemic Encephalopathy Mild | Neonatal EncephalopathyUnited States
-
The Hospital for Sick ChildrenCompletedKidney Failure, ChronicCanada
-
AmgenCompleted
-
Kyowa Kirin Co., Ltd.Completed
-
AmgenCompletedLymphoma | Breast Neoplasms | Lung Neoplasms | Multiple Myeloma | Chronic Lymphocytic Leukemia