An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: Granisetron; Drug: palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00666783

2006L01595

Details and patient eligibility

About

This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.

Enrollment: 208 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
• naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
• Karnofsky index more than 70% and anticipated survival time more than 90 days
• Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
• No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
• Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
• Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
• Provision of written informed consent

Exclusion criteria

• Inability to understand or cooperate with study procedures
• Receipt of investigational drugs 30 days before study entry
• Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
• Contraindications to 5-HT3 receptor antagonists
• Woman Patient with Pregnancy or lactation
• Diagnosed with hypertension or severe infectious diseases
• Obstructive symptom of gastrointestinal tract
• Symptomatic brain metastasis or mental dysfunction
• Baseline QTc > 500 ms

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

PAL

Experimental group

Description:

receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)

Treatment:

Drug: palonosetron

GRA

Active Comparator group

Description:

receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)

Treatment:

Drug: Granisetron