Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting (ESPNV)

Naval Military Medical University (Second Military Medical University)

Status and phase: Completed; Phase 4

Conditions: Neoplasms; Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: Palonosetron Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01481831

zhiruo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 599 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
3. Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
4. 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;
5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
6. Patients that voluntarily sign the consent form.

Exclusion criteria

1. Pregnancy, or patients during breast feeding;
2. Patients have accepted any radiotherapy during the experimental period;
3. Gastric outlet or intestinal obstruction;
4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
5. Patients have epilepsy, or have been used psychotropic drug and calm drug;
6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
8. Patients have known hypersensitivity to 5-HT3 antagonists;
9. Patients have chemotherapy contraindications;
10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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599 participants in 4 patient groups

H PALO day 1

Active Comparator group

Description:

Highly Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1

Treatment:

Drug: Palonosetron Hydrochloride

Drug: Palonosetron Hydrochloride

H PALO day 1,3,5

Experimental group

Description:

Highly Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5

Treatment:

Drug: Palonosetron Hydrochloride

Drug: Palonosetron Hydrochloride

M PALO day 1

Active Comparator group

Description:

Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1

Treatment:

Drug: Palonosetron Hydrochloride

Drug: Palonosetron Hydrochloride

M PALO day 1,3,5

Experimental group

Description:

Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5

Treatment:

Drug: Palonosetron Hydrochloride

Drug: Palonosetron Hydrochloride