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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00410488 |
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Date of registration:
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11/12/2006 |
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Primary sponsor: |
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Public title:
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Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
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Scientific title:
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Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI) |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00410488 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Saroj Vadhan-Raj, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nausea
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Sarcoma
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Vomiting
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Intervention(s)
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Drug: Adriamycin
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Drug: Dexamethasone
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Drug: Ifosfamide chemotherapy (AI)
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Drug: Mesna
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Drug: Palonosetron - Single Dose
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Drug: Palonosetron - Triple Dose
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Drug: Vincristine
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Drug: Zinecard
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Primary Outcome(s)
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Palonosetron Responses in the Study Cycle
[Time Frame: 10 days]
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Secondary ID(s)
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2005-0664
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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