Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 induced by highly emetogenic chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Emetics; Granisetron; Palonosetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.