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

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

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

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

Neoplasms

Chemotherapy-Induced Nausea and Vomiting

0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.

Palonosetron Hydrochloride

0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

Anhui Provincial Hospital

Chinese Academy of Medical Sciences Cancer Hospital

Chinese PLA 301 Hospital

Chinese PLA 307 Hospital

Chinese PLA Navy General Hospital

Fuzhou General Hospital of Nanjing Military Command

Guangxi Cancer Hospital

The Second Xiangya Hospital of Central South University

The First People's Hospital of Changzhou

Nanjing General Hospital of Nanjing Military Command

The First Affiliated Hospital of Soochow University

The Fourth People's Hospital of Wuxi

Shandong Cancer Hospital

Shandong Provincial Hospital

The Affiliated Hospital of Medical College Qingdao University

Shanghai Changzheng Hospital

Shanghai Xinhua Hospital

Tangdu Hospital of Fourth Military Medical University

Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China

defined as no emetic episode and no use of rescue medication

Zhan Wang

Principal Investigator

JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Patients receiving chemotherapy (anthracycline-based) will be randomized to esomeprazole for Cycle 1 Days 1-5 and Cycle 2 Days 1-5

Subjects will be given placebo Cycle 1 Days 1-5 and Cycle 2 Days 1-5.

Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.

Esomeprazole

Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.

Sugar Pill

Total

Age, Customized

Sex: Female, Male

Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.

The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.

The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.

Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication

Overall Study

Mothaffar Rimawi

The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.

Nausea

esomeprazole

Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5

arabinoside/vemšana

Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

Nexium Study To Suppress Nausea During Chemotherapy

Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site

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