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The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

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ClinicalTrials.gov Identifier: NCT01909856
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Palonosetron Drug: Granisetron Drug: Dexamethasone Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Study Start Date : October 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm1
1st cycle Palonosetron, 2nd cycle Granisetron
Drug: Palonosetron
Palonosetron 0.25mg d1,d3

Drug: Granisetron
Granisetron 3mg d1-3

Drug: Dexamethasone
Dexamethasone 10mg d1-3

Drug: Cisplatin
3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Experimental: Arm2
1st cycle Granisetron, 2nd cycle Palonosetron
Drug: Palonosetron
Palonosetron 0.25mg d1,d3

Drug: Granisetron
Granisetron 3mg d1-3

Drug: Dexamethasone
Dexamethasone 10mg d1-3

Drug: Cisplatin
3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3




Primary Outcome Measures :
  1. Complete Response(CR) within 24-120 hours after chemotherapy [ Time Frame: 24-120 hours ]

Secondary Outcome Measures :
  1. CR within 0-120 hours after chemotherapy [ Time Frame: 0-120 hours ]
  2. CR within 0-24 hours after chemotherapy [ Time Frame: 0-24 hours ]
  3. Incidence of Adverse events [ Time Frame: up to 3 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909856


Locations
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China, Hubei
Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Shiying Yu, MD Tongji Hospital

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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01909856     History of Changes
Other Study ID Numbers: sim-palonosetron
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Cisplatin
Palonosetron
Granisetron
Emetics
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents