NCT00117117

Brief Summary

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®.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,423

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2005

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

First QC Date

June 30, 2005

Last Update Submit

March 24, 2009

Conditions

Anemia

Keywords

Chemotherapy induced anemiaAmgenAranesp®darbepoetin alfa

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcomes

Secondary Outcomes (1)

  • Changes in hemoglobin endpoints and RBC transfusion requirements

Interventions

AranespDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.3816/SCT.2006.n.021.

    PMID: 18632499RESULT

  • 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. doi: 10.1002/cncr.22943.

    PMID: 17694552RESULT

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 4, 2005

Study Start

September 1, 2002

Study Completion

December 1, 2003

Last Updated

March 25, 2009

Record last verified: 2009-03