N/A
Completed N=50
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
Source: ClinicalTrials.gov NCT00410488 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Palonosetron Response Rate in the 10 Day Study Cycle — 31.25; 50 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palonosetron Response Rate in the 10 Day Study Cycle |
31.25; 50 | — |
Eligibility Criteria
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 /= 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.
Data sourced from ClinicalTrials.gov (NCT00410488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.