Status:
COMPLETED
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01909856
Start Date
October 1 2011
End Date
June 1 2014
Last Update
December 4 2015
Active Locations (1)
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1
Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030