Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.

Detailed Description
-----------------
Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program. Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2. Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.

Official Title
-----------------
A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China

Conditions
-----------------
Neoplasms, Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Palonosetron Hydrochloride
* Drug: Palonosetron Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease; The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy); Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months; WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation; Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks); Patients that voluntarily sign the consent form. Exclusion Criteria: Pregnancy, or patients during breast feeding; Patients have accepted any radiotherapy during the experimental period; Gastric outlet or intestinal obstruction; Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder; Patients have epilepsy, or have been used psychotropic drug and calm drug; Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy; Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self; Patients have known hypersensitivity to 5-HT3 antagonists; Patients have chemotherapy contraindications; Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H PALO day 1<br>Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 | Drug: Palonosetron Hydrochloride<br>* 0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.<br>|
| Experimental: H PALO day 1,3,5<br>Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 | Drug: Palonosetron Hydrochloride<br>* 0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.<br>|
| Active Comparator: M PALO day 1<br>Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 | Drug: Palonosetron Hydrochloride<br>* 0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.<br>|
| Experimental: M PALO day 1,3,5<br>Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 | Drug: Palonosetron Hydrochloride<br>* 0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response rate | defined as no emetic episode and no use of rescue medication | 2-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response rate | defined as no emetic episode and no use of rescue medication | 0-24 hours, 0-7 days |