The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Palonosetron; Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
• The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
• Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
• Life expectancy ≥ 3 months;
• Adequate hematologic function;
• Adequate hepatic function;
• Adequate renal function;
• At least 2 weeks away from the last chemotherapy;
• Patients signed written informed consent.

Exclusion Criteria:

• Pregnant or lactating women;
• History of anticipatory vomiting;
• Radiation therapy on the abdomen or pelvis within one week prior to study entry;
• Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
• Patients with gastrointestinal obstruction;
• Patients with severe heart disease, liver or renal disease, or metabolism disorders;
• Patients with epilepsy or using sedative or psychotropic drugs;
• Patients with diabetes or with contraindication for corticosteroids;
• Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
• Patients with brain metastasis or intracranial hypertension;
• Hypersensitivity to 5-HT3 receptor antagonist;
• Patients with active infection;
• Other conditions that the investigator considered as unsuitable for chemotherapy;
• Subjects participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm1; 1st cycle Palonosetron, 2nd cycle Granisetron	Drug: Palonosetron; Palonosetron 0.25mg d1,d3; Drug: Granisetron; Granisetron 3mg d1-3; Drug: Dexamethasone; Dexamethasone 10mg d1-3; Drug: Cisplatin; 3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3
Experimental: Arm2; 1st cycle Granisetron, 2nd cycle Palonosetron	Drug: Palonosetron; Palonosetron 0.25mg d1,d3; Drug: Granisetron; Granisetron 3mg d1-3; Drug: Dexamethasone; Dexamethasone 10mg d1-3; Drug: Cisplatin; 3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete Response(CR) within 24-120 hours after chemotherapy	24-120 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
CR within 0-120 hours after chemotherapy	0-120 hours
CR within 0-24 hours after chemotherapy	0-24 hours
Incidence of Adverse events	up to 3 months

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Shiying Yu, MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone; Cisplatin; Palonosetron; Granisetron
• Other Study ID Numbers: sim-palonosetron