Clinical trial · Interventional
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)
NCT00410488CI-TRIAL-00009802completedN/AResults postedClinicalTrials.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)
The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ifosfamide chemotherapy (AI) | Drug | — | UNRESOLVED |
| Mesna | Drug | — | UNRESOLVED |
| Palonosetron - Single Dose | Drug | — | UNRESOLVED |
| Palonosetron - Triple Dose | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
| Zinecard | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Palonosetron - 1 Dose
- description
- Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0). Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
- interventionNames
- Drug: Palonosetron - Single Dose
- Drug: Adriamycin
- Drug: Ifosfamide chemotherapy (AI)
- Drug: Zinecard
- Drug: Mesna
- Drug: Vincristine
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Palonosetron - 3 Doses
- description
- Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4). Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
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 relapse or metastatic for whom treatment with AI is indicated. * Must be between the ages of 18 and 65 years of age. * Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control. * Adequate hematologic (Absolute neutrophil count (ANC)\>/= 1500/mm\^3, \>/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count \>/= 150,000/mm\^3), renal (serum creatinine \</= 1.5 mg/dL), hepatic (serum bilirubin count \</= 1.5 \* normal and Serum glutamic pyruvic transaminase (SGPT) \<3 \* normal) functions. * Karnofsky Performance Status \>/= 80. * Signed informed consent form. Exclusion Criteria: * Pregnant or lactating women. * Patients with comorbid condition which renders patients at high risk of treatment complication. * Patients with symptomatic or untreated metastatic disease to CNS. * Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia. * Patients with known hypersensitivity to 5-HT3 antagonists. * Any vomiting or \>/= grade 2 nausea in the 24 hours preceding chemotherapy. * Ongoing vomiting from any organic etiology. * Radiotherapy within 2 weeks of study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.