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

NCT00666783 | Completed Phase 2

• 1 other identifier: 2006L01595
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Study Arms (2)

PAL

EXPERIMENTAL

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

Drug: palonosetron

GRA

ACTIVE COMPARATOR

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

Drug: Granisetron

Interventions

palonosetron DRUG

receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.

PAL

Granisetron DRUG

receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.

GRA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijng Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Vomiting

Interventions

Palonosetron; Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Bridged Bicyclo Compounds, Heterocyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Last Updated: April 25, 2008

Record last verified: 2006-08

Locations

CN (1)