Clinical trial · Interventional
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
NCT00283621CI-TRIAL-00035656completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Aranesp (darbepoetin alfa) | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Neulasta (pegfilgrastim) | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Growth Factors + Adriamycin/Ifosfamide
- description
- Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
- interventionNames
- Drug: Aranesp (darbepoetin alfa)
- Drug: Neulasta (pegfilgrastim)
- Drug: Adriamycin
- Drug: Ifosfamide
Primary outcomes (3)
- measure
- CBC diff/platelet counts
- timeFrame
- Monitored at least twice a week and daily during severe myelosuppression.
- measure
- Iron Stores
- timeFrame
- Blood drawn at baseline during cycle 3 and at the end of study.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated * Must be between 18-65 years of age * Women of childbearing potential should use effective contraceptive measures * Adequate hematologic, renal, and hepatic functions * Karnofsky performance status above or equal to 80 Exclusion Criteria: * Pregnant or lactating women. * Patients with comorbid condition which renders patients at high risk of treatment complication * Patients with metastatic disease to CNS * Patients with significant cardiac abnormalities * History of seizure disorder in the past 5 years * Patient has received any packed red blood cell transfusion within 2 weeks before study entry * Prior surgery or radiation therapy within 2 weeks of study entry * History of prior chemotherapy for sarcomas * Iron deficiency * Hypersensitivity to E.coli derived products
References
Publications (0)
Data not yet available
No reference posted for this study.