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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909856
• Other study ID #: sim-palonosetron
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2013
• Last updated: December 2, 2015
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Palonosetron
Palonosetron 0.25mg d1,d3
• Granisetron
Granisetron 3mg d1-3
• Dexamethasone
Dexamethasone 10mg d1-3
• Cisplatin
3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Locations

Country	Name	City	State
China	Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response(CR) within 24-120 hours after chemotherapy		24-120 hours	No
Secondary	CR within 0-120 hours after chemotherapy		0-120 hours	No
Secondary	CR within 0-24 hours after chemotherapy		0-24 hours	No
Secondary	Incidence of Adverse events		up to 3 months	Yes