Status:
COMPLETED
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Conditions:
Sarcoma
Nausea
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Palonosetron is a drug that is designed to prevent and treat nausea and vomiting that is caused by chemotherapy. If you are found to be eligible to take part in this study, you will have several bloo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00410488
Start Date
December 1 2006
End Date
June 1 2011
Last Update
March 22 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030