Know Cancer

forgot password

Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy

Phase 3
20 Years
Not Enrolling
Chemotherapy-Induced Nausea and Vomiting

Thank you

Trial Information

Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy

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 verify 0.75 mg palonosetron, concomitantly administered with
corticosteroids, is not inferior and superior to granisetron hydrochloride in acute stages 0
- 24 hours and in delayed stages 24 - 120 hours after administration of highly emetogenic
chemotherapy, respectively. Corticosteroids are commonly employed in current medical
treatments with 5-HT3 receptor antagonists.

This is a multicenter, parallel, group comparative study where subjects are assigned to
treatment groups in accordance with a central registration system. After obtaining written
informed consent, the patients that satisfy the inclusion criteria without meeting the
exclusion criteria are assigned using minimizing procedures to either a single-dose of 0.75
mg palonosetron group or a single-dose of 40 μg/kg granisetron hydrochloride with covariates
of chemotherapy regimen, gender and age. A palonosetron group will receive intravenous
injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration
of highly emetogenic chemotherapy. A granisetron hydrochloride group will be treated with
palonosetron placebo and then intravenous 40μg/kg granisetron hydrochloride before
administration of highly emetogenic chemotherapy. The onset of nausea and emetic episodes
and the time of an antiemetic procedure will be observed for 120 hours after the start of
highly emetogenic chemotherapy. The objective is to find the patients' global satisfaction
with the antiemetic therapy. Adverse events will also be observed for seven days after the
administration of the each drug.

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:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting

Principal Investigator

Tomohide Tamura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

July 2006

Completion Date:

August 2007

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • nausea and vomiting
  • Nausea
  • Vomiting