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

Simcere

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin; Drug: Palonosetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909856

sim-palonosetron

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups

Arm1

Experimental group

Description:

1st cycle Palonosetron, 2nd cycle Granisetron

Treatment:

Drug: Cisplatin

Drug: Granisetron

Drug: Dexamethasone

Drug: Palonosetron

Arm2

Experimental group

Description:

1st cycle Granisetron, 2nd cycle Palonosetron

Treatment:

Drug: Cisplatin

Drug: Granisetron

Drug: Dexamethasone

Drug: Palonosetron