Anemia in Patients With a Non-Myeloid Malignancy

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00038064

Collaborator

(none)

707

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Anemia	Drug: Darbepoetin alfa Drug: rHuEPO	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

707 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rHuEPO	Drug: rHuEPO 150 IU/kg TIW
Experimental: Darbepoetin alfa	Drug: Darbepoetin alfa Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

Arm

Intervention/Treatment

Active Comparator: rHuEPO

Drug: rHuEPO

150 IU/kg TIW

Experimental: Darbepoetin alfa

Drug: Darbepoetin alfa

Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

Outcome Measures

Primary Outcome Measures

Time to first hemoglobin response during the treatment period [during the treatment period]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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