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

NCT ID: NCT01909856

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm1

1st cycle Palonosetron, 2nd cycle Granisetron

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

Palonosetron 0.25mg d1,d3

Granisetron

Intervention Type DRUG

Granisetron 3mg d1-3

Dexamethasone

Intervention Type DRUG

Dexamethasone 10mg d1-3

Cisplatin

Intervention Type DRUG

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Arm2

1st cycle Granisetron, 2nd cycle Palonosetron

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

Palonosetron 0.25mg d1,d3

Granisetron

Intervention Type DRUG

Granisetron 3mg d1-3

Dexamethasone

Intervention Type DRUG

Dexamethasone 10mg d1-3

Cisplatin

Intervention Type DRUG

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Interventions

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Palonosetron

Palonosetron 0.25mg d1,d3

Intervention Type DRUG

Granisetron

Granisetron 3mg d1-3

Intervention Type DRUG

Dexamethasone

Dexamethasone 10mg d1-3

Intervention Type DRUG

Cisplatin

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiying Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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sim-palonosetron

Identifier Type: -

Identifier Source: org_study_id