The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Phase 2
Completed
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT01909856
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- 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 granisetron is the positive control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm1 Palonosetron 1st cycle Palonosetron, 2nd cycle Granisetron Arm1 Cisplatin 1st cycle Palonosetron, 2nd cycle Granisetron Arm1 Granisetron 1st cycle Palonosetron, 2nd cycle Granisetron Arm1 Dexamethasone 1st cycle Palonosetron, 2nd cycle Granisetron Arm2 Palonosetron 1st cycle Granisetron, 2nd cycle Palonosetron Arm2 Granisetron 1st cycle Granisetron, 2nd cycle Palonosetron Arm2 Cisplatin 1st cycle Granisetron, 2nd cycle Palonosetron Arm2 Dexamethasone 1st cycle Granisetron, 2nd cycle Palonosetron
- Primary Outcome Measures
Name Time Method Complete Response(CR) within 24-120 hours after chemotherapy 24-120 hours
- Secondary Outcome Measures
Name Time Method CR within 0-120 hours after chemotherapy 0-120 hours CR within 0-24 hours after chemotherapy 0-24 hours Incidence of Adverse events up to 3 months
Trial Locations
- Locations (1)
Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China