Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Cancer Clinical Trial

Official title:

A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111137
• Other study ID #: 20020139
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2005
• Last updated: February 20, 2008
• Start date: February 2003
• Est. completion date: April 2004

Study information

• Verified date: February 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 718
• Est. completion date: April 2004
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more

• Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy

• Karnofsky performance status of greater than or equal to 50%

• Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

• Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes

• Hematologic disorder previously associated with anemia

• Active bleeding

• Iron deficiency

• Received erythropoietic therapy within 14 days prior to randomization

• Unstable cardiac disease

• Known positive human immunodeficiency virus antibody or hepatitis B surface antigen

• Known positive antibody response to any erythropoietic agent

• Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication

• Pregnant or breast feeding

• Red blood cell (RBC) transfusion within 4 weeks of screening

• Known hypersensitivity to any recombinant mammalian-derived product

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Drug:
• rHuEPO
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
• Darbepoetin alfa
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hematopoietic response during the comparative treatment period		during the comparative treatment period	No
Secondary	Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)		during the study	No
Secondary	Incidence, if any, of neutralizing antibody formation to study drug		throughout study	Yes
Secondary	Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin		baseline to first month of treatment	No
Secondary	Time to 2 g/dL increase in hemoglobin during the comparative treatment period		during the comparative treatment period	No
Secondary	Change in FACT-Fatigue scale score over time during the comparative treatment period		during the comparative treatment period	No
Secondary	Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study		throughout study	Yes
Secondary	Slope of change in hemoglobin after the first month of treatment		baseline to first month of treatment	No
Secondary	Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period		during the comparative treatment period	No
Secondary	Changes in hemoglobin during the maintenance period		during the maintenance period	No

External Links

•   AmgenTrials clinical trials website