Status:
COMPLETED
Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting ...
Detailed Description
This study involves prophylactic single dose of granisetron hydrochloride as a control in the treatment of chemotherapy induced nausea and vomiting (CINV). The primary objective of the study is to ver...
Eligibility Criteria
Inclusion
- Patients aged 20 or more at the time when they give consent.
- Diagnosed as malignant disease.
- Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
- Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
- WBC ≥ 3000 /mm3 AST \< 100 IU/L ALT \< 100 IU/L Creatinine clearance ≥ 60 mL/min
- Performance Status : 0 - 2
Exclusion
- Severe (requiring hospitalization) and uncontrollable complications.
- Metastases to the brain which are symptomatic.
- Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
- Symptomatic and invasive procedure indicated ascites or pleural effusion.
- Have either gastric outlet stenosis or intestinal obstruction.
- Have ongoing emesis or CTCAE grade 2 or greater nausea.
- QTc \> 470 msec in the 12-lead ECG within eight days before registration.
- Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
- Known anaphylactic to ingredients of dexamethasone.
- Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT00359567
Start Date
July 1 2006
End Date
August 1 2007
Last Update
July 7 2011
Active Locations (1)
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1
National Cancer Center
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045