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

Study Overview
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Palonosetron
* Drug: Granisetron
* Drug: Dexamethasone
* Drug: Cisplatin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |