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

NCT ID: NCT00666783

Last Updated: 2008-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy-Induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Study Groups

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PAL

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

Group Type EXPERIMENTAL

palonosetron

Intervention Type DRUG

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

GRA

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

Group Type ACTIVE_COMPARATOR

Granisetron

Intervention Type DRUG

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

Interventions

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palonosetron

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

Intervention Type DRUG

Granisetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Clinical trial center of Xijing Hospital

Locations

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Xijng Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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2006L01595

Identifier Type: -

Identifier Source: org_study_id