NCT00315484

Brief Summary

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2003

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

February 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

April 14, 2006

Last Update Submit

May 17, 2011

Conditions

AnemiaChemotherapy

Keywords

Anemiachemotherapyhemoglobin levelrecombinant human erythropoietinepoetin alfadarbepoetin alfa

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.

Secondary Outcomes (1)

  • 1) time to hemoglobin (Hgb) increase of 1g/dL; 2) proportion of pts achieving a >1 g/dL Hgb increase by Wk 9; 3) proportion of pts achieving a >2g/dL Hgb increase by Wk 9; 4) Hgb values over time; 5) cumulative RBC transfusion Wk 5 to end of study

Interventions

Epoetin alfa and Darbepoetin alfaDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of a solid tumor malignancy
  • Baseline hemoglobin value of \<11 g/dL
  • Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
  • \< 2 prior chemotherapy regimens in a metastatic setting
  • Adequate hematologic \& renal function and platelet count \>100,000/mm3
  • Estimated life expectancy of \> 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

You may not qualify if:

  • History of stem cell or bone marrow transplant
  • Anemia due to factors other than cancer/chemotherapy
  • Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months
  • Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
  • Uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
  • new onset of seizures
  • history of second active malignancy
  • Major infection requiring hospitalization and antibiotics within 14 days of randomization
  • Transfusion of white blood cells or packed red blood cells within 28 days of randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Waltzman R, Croot C, Justice GR, Fesen MR, Charu V, Williams D. Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 microg every 2 weeks) in anemic patients with cancer receiving chemotherapy. Oncologist. 2005 Sep;10(8):642-50. doi: 10.1634/theoncologist.10-8-642.

    PMID: 16177289RESULT

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Epoetin AlfaDarbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ortho Biotech Products, L.P. Clinical Trial

    Ortho Biotech Products, L.P.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

February 1, 2003

Study Completion

October 1, 2004

Last Updated

May 19, 2011

Record last verified: 2010-04