Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting (ESPNV)
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Purpose
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Chemotherapy-Induced Nausea and Vomiting |
Drug: Palonosetron Hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Complete Response rate [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]defined as no emetic episode and no use of rescue medication
- Complete Response rate [ Time Frame: 0-24 hours, 0-7 days ] [ Designated as safety issue: No ]defined as no emetic episode and no use of rescue medication
| Enrollment: | 599 |
| Study Start Date: | July 2011 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: H PALO day 1
Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
|
Drug: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
|
|
Experimental: H PALO day 1,3,5
Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
|
Drug: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
|
|
Active Comparator: M PALO day 1
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
|
Drug: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
|
|
Experimental: M PALO day 1,3,5
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
|
Drug: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
|
Detailed Description:
Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.
Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2.
Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
- The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
- Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
- WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
- Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
- Patients that voluntarily sign the consent form.
Exclusion Criteria:
- Pregnancy, or patients during breast feeding;
- Patients have accepted any radiotherapy during the experimental period;
- Gastric outlet or intestinal obstruction;
- Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- Patients have epilepsy, or have been used psychotropic drug and calm drug;
- Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
- Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
- Patients have known hypersensitivity to 5-HT3 antagonists;
- Patients have chemotherapy contraindications;
- Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
Contacts and Locations| China, Anhui | |
| Anhui Provincial Hospital | |
| Hefei, Anhui, China | |
| China, Beijing | |
| Chinese PLA 301 Hospital | |
| Beijing, Beijing, China | |
| Chinese PLA 307 Hospital | |
| Beijing, Beijing, China | |
| Chinese PLA Navy General Hospital | |
| Beijing, Beijing, China | |
| Chinese Academy of Medical Sciences Cancer Hospital | |
| Beijing, Beijing, China | |
| China, Fujian | |
| Fuzhou General Hospital of Nanjing Military Command | |
| Fuzhou, Fujian, China | |
| China, Guangxi | |
| Guangxi Cancer Hospital | |
| Nanning, Guangxi, China | |
| China, Hunan | |
| The Second Xiangya Hospital of Central South University | |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| The First People's Hospital of Changzhou | |
| Changzhou, Jiangsu, China | |
| Nanjing General Hospital of Nanjing Military Command | |
| Nanjing, Jiangsu, China | |
| The First Affiliated Hospital of Soochow University | |
| Suzhou, Jiangsu, China | |
| The Fourth People's Hospital of Wuxi | |
| Wuxi, Jiangsu, China | |
| China, Shandong | |
| Shandong Provincial Hospital | |
| Jinan, Shandong, China | |
| Shandong Cancer Hospital | |
| Jinan, Shandong, China | |
| The Affiliated Hospital of Medical College Qingdao University | |
| Qingdao, Shandong, China | |
| China, Shanghai | |
| Shanghai Changzheng Hospital | |
| Shanghai, Shanghai, China | |
| Shanghai Xinhua Hospital | |
| Shanghai, Shanghai, China | |
| China, Shanxi | |
| Tangdu Hospital of Fourth Military Medical University | |
| Xian, Shanxi, China | |
More Information
No publications provided
| Responsible Party: | Zhan Wang, Principal Investigator, Shanghai Changzheng Hospital |
| ClinicalTrials.gov Identifier: | NCT01481831 History of Changes |
| Other Study ID Numbers: | zhiruo |
| Study First Received: | October 28, 2011 |
| Last Updated: | December 28, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Palonosetron |
Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013