Clinical trial NCT00038064: Anemia in Patients With a Non-Myeloid Malignancy
Official title: A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Anemia
Keywords: anemia of cancer/chemotherapy
non-myeloid malignancies
Drug Therapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-29
Enrollment: 707
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: Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.


Eligibility criteria: Inclusion Criteria:

* Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0 g/dL
* ECOG performance status of 0 to 2 (inclusive)

Exclusion Criteria:

* History of seizure disorder
* Primary hematologic disorder that could cause anemia
* Unstable or uncontrolled disease/condition related to or affecting cardiac function
* Clinical evidence of chronic infection/inflammatory disease
* Positive test for HIV infection
* Previously confirmed neutralizing antibodies to rHuEPO
* Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences

Primary outcomes:
measure: Time to first hemoglobin response during the treatment period
timeFrame: during the treatment period
Secondary outcomes:
measure: Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
timeFrame: throughout study
measure: Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
timeFrame: throughout study
measure: Average weekly dosage of study drug during the 16-week treatment period
timeFrame: 16-week treatment period
measure: Receiving red blood cell (RBC) transfusion from week 5 to week 12
timeFrame: from week 5 to week 12
measure: Change in FACT-Fatigue scale score from baseline to week 7
timeFrame: from baseline to week 7
measure: Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
timeFrame: throughout study
measure: Profile of change in FACT-Fatigue scale score from baseline over the treatment period
timeFrame: from baseline over the treatment period
measure: Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
timeFrame: from baseline to EOTP
measure: Change in FACT-Physical Well-being scale score from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Receiving RBC transfusion during the treatment period
timeFrame: during the treatment period
measure: Number of units of RBC transfused during the treatment period
timeFrame: during the treatment period
measure: Achieving a hemoglobin response by week 7
timeFrame: baseline to week 7
measure: Change in hemoglobin concentration from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Time to first hematopoietic response
timeFrame: throughout study
measure: Achieving a hemoglobin correction
timeFrame: throughout study
measure: Number and percentage of subjects who exceed the hemoglobin concentration threshold
timeFrame: throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: