Clinical trial NCT00035607: Chemotherapy Related Anemia
Official title: A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Non-Myeloid Malignancies
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a non-myeloid malignancy
* Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0g/dL
* ECOG performance status of 0 to 2
* Adequate renal and liver function

Exclusion Criteria:

* History of seizure disorder
* Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
* More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1

Primary outcomes:
measure: Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
timeFrame: from baseline to the end of treatment period (EOTP)
Secondary outcomes:
measure: Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
timeFrame: throughout study
measure: Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
timeFrame: from baseline to week 7 and from week 7 to EOTP
measure: Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
timeFrame: during the treatment period
measure: Time to and percentage of subjects with a hemoglobin response during the treatment period
timeFrame: during the treatment period
measure: Percentage of subjects who exceed the hemoglobin threshold
timeFrame: throughout study
measure: Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
timeFrame: throughout study
measure: Incidence, if any, of neutralizing antibody formation to darbepoetin alfa
timeFrame: throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.