Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting
NCT ID: NCT00503386
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2006-04-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Interventions
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Palonosetron
Granisetron
Eligibility Criteria
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Inclusion Criteria
* Malignant disease
* Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
* Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 \~ 80 mg/m2 on study Day 1
* Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
* Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
* Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
* Predicted life expectancy of ≥ 3 months
* Provision of written informed consent.
Exclusion Criteria
* Receipt of investigational drugs ≤ 30 days before study entry
* Receipt of other investigational drugs during the course of this study
* Seizure disorder or any condition requiring anticonvulsants, sedatives
* CNS malignancy or metastasis
* Ongoing emesis due to obstruction of digestive tract
* Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
* Moderate or severe nausea and vomiting after any previous chemotherapy
* Scheduled receipt of any chemotherapeutic agent with an emetogenicity level \>3 during study Days 2-5
* Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
* Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
* Contraindications to 5-HT3 receptor antagonists
* Contraindications to chemotherapy
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Tigermed Consulting Co., Ltd
INDUSTRY
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
INDUSTRY
Principal Investigators
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Tongyu Lin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
Jiangsu Provincial Tumor Hospital
Nanjing, Jiangsu, China
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, China
Beijing Institute on Thoracic Cancer and Tuberculosis
Beijing, , China
Countries
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References
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Tian W, Wang Z, Zhou J, Zhang S, Wang J, Chen Q, Huang C, Pan L, Zhang L, Huang J, Shen H, Lin T. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2011 Mar;28(1):71-8. doi: 10.1007/s12032-009-9398-2. Epub 2010 Jan 5.
Related Links
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Publication: Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2010 Jan 5. \[Epub ahead of print\]
Other Identifiers
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HJGene_SYat-sen_06_01
Identifier Type: -
Identifier Source: org_study_id