Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111137
First received: May 17, 2005
Last updated: February 20, 2008
Last verified: February 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Non-Myeloid Malignancies |
Drug: rHuEPO Drug: Darbepoetin alfa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to hematopoietic response during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Incidence, if any, of neutralizing antibody formation to study drug [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
- Time to 2 g/dL increase in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
- Change in FACT-Fatigue scale score over time during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
- Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Slope of change in hemoglobin after the first month of treatment [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
- Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
- Changes in hemoglobin during the maintenance period [ Time Frame: during the maintenance period ] [ Designated as safety issue: No ]
| Enrollment: | 718 |
| Study Start Date: | February 2003 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: rHuEPO |
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.
|
| Experimental: Darbepoetin alfa |
Drug: Darbepoetin alfa
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00111137 History of Changes |
| Other Study ID Numbers: | 20020139 |
| Study First Received: | May 17, 2005 |
| Last Updated: | February 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
darbepoetin alfa anemia Amgen Chemotherapy |
Additional relevant MeSH terms:
|
Neoplasms Darbepoetin alfa Epoetin Alfa Hematinics |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013