Anemia in Patients With a Non-Myeloid Malignancy
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00038064
First received: May 28, 2002
Last updated: September 11, 2008
Last verified: September 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms Anemia |
Drug: Darbepoetin alfa Drug: rHuEPO |
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 of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to first hemoglobin response during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Average weekly dosage of study drug during the 16-week treatment period [ Time Frame: 16-week treatment period ] [ Designated as safety issue: Yes ]
- Receiving red blood cell (RBC) transfusion from week 5 to week 12 [ Time Frame: from week 5 to week 12 ] [ Designated as safety issue: No ]
- Change in FACT-Fatigue scale score from baseline to week 7 [ Time Frame: from baseline to week 7 ] [ Designated as safety issue: No ]
- Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Profile of change in FACT-Fatigue scale score from baseline over the treatment period [ Time Frame: from baseline over the treatment period ] [ Designated as safety issue: No ]
- Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP) [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Change in FACT-Physical Well-being scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Receiving RBC transfusion during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
- Number of units of RBC transfused during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
- Achieving a hemoglobin response by week 7 [ Time Frame: baseline to week 7 ] [ Designated as safety issue: No ]
- Change in hemoglobin concentration from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Time to first hematopoietic response [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Achieving a hemoglobin correction [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Number and percentage of subjects who exceed the hemoglobin concentration threshold [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
| Enrollment: | 707 |
| Study Start Date: | January 2002 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00038064 History of Changes |
| Obsolete Identifiers: | NCT00046982 |
| Other Study ID Numbers: | 20010101 |
| Study First Received: | May 28, 2002 |
| Last Updated: | September 11, 2008 |
| Health Authority: | Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Canada: Health Canada Denmark: Laegemiddelstyrelsen Finland: Lääkelaitos France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Australia: Therapeutic Goods Administration Austria: Bundesamt für Sicherheit im Gesundheitswesen |
Keywords provided by Amgen:
|
anemia of cancer/chemotherapy non-myeloid malignancies Drug Therapy |
Additional relevant MeSH terms:
|
Anemia Neoplasms Hematologic Diseases Darbepoetin alfa Epoetin Alfa |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013