Overview

Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Eisai Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Dexrazoxane
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Mesna
Palonosetron
Razoxane
Vincristine
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 mg/dL), hepatic (serum bilirubin count 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.