Darbepoetin Alfa and Anemia of Cancer
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 11/30/2013 |
| Primero enviado: | 09/30/2009 |
| Inscripción estimada enviada: | 09/30/2009 |
| Publicado por primera vez: | 10/01/2009 |
| Última actualización enviada: | 12/10/2013 |
| Última actualización publicada: | 01/28/2014 |
| Fecha de los primeros resultados enviados: | 09/02/2010 |
| Fecha de los primeros resultados de CC enviados: | 12/10/2013 |
| Fecha de los primeros resultados publicados: | 01/28/2014 |
| Fecha de inicio real del estudio: | 04/30/2002 |
| Fecha estimada de finalización primaria: | 12/31/2003 |
| Fecha estimada de finalización del estudio: | 05/31/2004 |
Condición o enfermedad
Intervención / tratamiento
Biological: darbepoetin alfa
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Other: Observational Group Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. | |
| Active Comparator: 21 week treatment group Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - nonmyeloid malignancies (including lymphocytic leukemias) - anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy - Eastern Cooperative Oncology Group performance status of 0 to 2 - adequate liver and renal functions - 18 years or older Exclusion Criteria: - history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening - acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome - known hematologic disorders that could cause anemia - inflammatory or cardiac disorders - previous positive antibody response to any erythropoietic agent - history of pure red cell aplasia |
Salir
Medidas de resultado primarias
1. Number of Participants Hospitalized During the Test Period [Weeks 1- 12]
2. Days of Hospitalization During the Test Period [Weeks 1-12]
3. Number of Hospitalizations During the Test Period [Weeks 1-12]
Medidas de resultado secundarias
1. Total Hospital Costs During the Test Period [Weeks 1-12]
2. Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13 [Baseline (Week 1) and Week 13]
3. Hemoglobin Response During the Test Period [Weeks 1-12]
4. Hematopoietic Response During the Test Period [Weeks 1-12]
5. Change From Baseline in Hemoglobin Level [Baseline (Week 1) and Week 13]
6. Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period [Weeks 1-12]
7. Number of Units of Red Blood Cells Transfused During the Test Period [Weeks 1-12]
8. Number of Days of Red Blood Cell Transfusions During the Test Period [Weeks 1-12]
9. Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12 [Weeks 5-12]
10. Number of Units of Red Blood Cells Transfused During Weeks 5-12 [Weeks 5-12]
11. Number of Days of Red Blood Cell Transfusions During Weeks 5-12 [Weeks 5-12]
