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The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 (Primary Prophylaxis) | Experimental | Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1 |
|
| Treatment Group 2 (Secondary Prophylaxis) | Active Comparator | Per Investigator's discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neulasta (pegfilgrastim) | Drug | Commercial pegfilgrastim 6mg single subcutaneous fixed-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day | End of the last cycle of chemotherapy or the date of early termination from the study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 and 4 neutropenia | End of the last cycle of chemotherapy or the date of early termination from the study | |
| Dose delays or dose reductions | End of the last cycle of chemotherapy or the date of early termination from the study |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18165618 | Result | Balducci L, Al-Halawani H, Charu V, Tam J, Shahin S, Dreiling L, Ershler WB. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007 Dec;12(12):1416-24. doi: 10.1634/theoncologist.12-12-1416. | |
| 20118030 | Result | Flores IQ, Ershler W. Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clin J Oncol Nurs. 2010 Feb;14(1):81-6. doi: 10.1188/10.CJON.81-86. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day | End of the last cycle of chemotherapy or the date of early termination from the study |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D008228 | Lymphoma, Non-Hodgkin |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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