Clinical trial NCT00091858: Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Cancer
Keywords: Cancer-related anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-09-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* subjects with non-myeloid malignancies
* anemia due to cancer
* ECOG status 0 to 2
* greater than or equal to 4-month expectancy
* greater than or equal to 18 years and of legal age for informed consent
* screening hemoglobin concentration less than or equal to 11.0g/dL
* adequate serum folate and vitamin B12
* adequate renal and liver function
* written informed consent

Exclusion Criteria:

* subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
* in complete remission, as determined by the investigator
* subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
* documented history of pure red cell aplasia
* Known history of seizure disorder
* cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* uncontrolled hypertension
* clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
* iron deficiency
* known positive test for HIV infection
* previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
* received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
* less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* pregnant or breast feeding
* subject of reproductive potential who is not using adequate contraceptive precautions
* known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
* previously randomized into this study
* concerns for subject's compliance with the protocol procedures

Primary outcomes:
measure: Occurrences of red blood cell transfusion
timeFrame: from study day 29 (week 5) to week 17
Secondary outcomes:
measure: Incidence of first red blood cell transfusion
timeFrame: from week 5 (study day 29) to week 17 (study day 119)
measure: Change in hemoglobin concentration measured
timeFrame: from baseline (study day 1) to EOTP
measure: Adverse events and serious adverse events
timeFrame: throughout study for subjects who received at least 1 dose of investigational product
measure: Survival
timeFrame: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product
measure: Incidence, if any, of neutralizing antibody formation to investigational product
timeFrame: throughout study for subjects who received at least 1 dose of investigational product
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.