A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

This study has been completed.

First Received: June 30, 2005 Last Updated: March 24, 2009 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117117

Purpose

The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.

Condition	Intervention	Phase
Anemia	Drug: Aranesp	Phase IV

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Further study details as provided by Amgen:

Primary Outcome Measures:

Patient reported outcomes

Secondary Outcome Measures:

Changes in hemoglobin endpoints and RBC transfusion requirements

Estimated Enrollment:	2423
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with nonmyeloid malignancy(ies)
Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy

Exclusion Criteria:

Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS)
Unstable cardiac disease or anemia due to other causes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117117

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Gregory SA. Efficacy of Darbepoetin Alfa in the Treatment of Chemotherapy-Induced Anemia in Non-Hodgkin's Lymphoma. Support Cancer Ther. 2006 Jul 1;3(4):232-9.

Gabrilove JL, Perez EA, Tomita DK, Rossi G, Cleeland CS. Assessing symptom burden using the M. D. Anderson symptom inventory in patients with chemotherapy-induced anemia: results of a multicenter, open-label study (SURPASS) of patients treated with darbepoetin-alpha at a dose of 200 microg every 2 weeks. Cancer. 2007 Oct 1;110(7):1629-40.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020132
Study First Received:	June 30, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00117117 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Amgen:

Chemotherapy induced anemia
Amgen
Aranesp®
darbepoetin alfa

Study placed in the following topic categories:

Hematinics
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009