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Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

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ClinicalTrials.gov Identifier: NCT02445872
Recruitment Status : Unknown
Verified August 2015 by Qiong Zhao, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2015
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

Brief Summary:
Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Nausea and Vomiting Lung Cancer Drug: Aprepitant Drug: Palonosetron Drug: Dexamethasone Phase 2

Detailed Description:
Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2015 V1).The patient should receive a 3-day cisplatin-based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant(125 mg po at day1, 80 mg at day2-3) combination with palonosetron and dexamethasone(5mg iv at day1-3, 3.75mg po at day4-5). In placebo group patients would receive palonosetron and dexamethasone(5mg iv at day1-3, 7.5mg po at day4-5).During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy
Study Start Date : December 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arm Intervention/treatment
Experimental: Arm A
Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
Drug: Aprepitant
Aprepitant:The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3
Other Name: Emend

Drug: Palonosetron
Drug: Dexamethasone
Active Comparator: Arm B
Palonosetron: 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 7.5mg PO on days 4-5.
Drug: Palonosetron
Drug: Dexamethasone



Primary Outcome Measures :
  1. Complete Response [ Time Frame: 5 days after the end of chemotherapy ]
    The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase


Secondary Outcome Measures :
  1. Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea) [ Time Frame: 5 days after the end of chemotherapy ]
    No emetic episode, no need for rescue medication, with a maximum grade of mild nausea

  2. Emesis-free [ Time Frame: 5 days after the end of chemotherapy ]
    Percentage of patients without emetic episodes

  3. Presence of nausea [ Time Frame: 5 days after the end of chemotherapy ]
    Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

  4. Safety and tolerability (adverse events related to study drug administration) [ Time Frame: 5 days after the end of chemotherapy ]
    Number of patients experienced at least one adverse events related to study drug administration.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who was confirmed lung cancer by pathologic histology or cytology.
  2. Males or females aged ≥18 years, <80 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
  4. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
  5. Patients with asymptomatic, treated brain metastases are eligible for trial participation.
  6. Adequate bone marrow, renal, and liver function are required.
  7. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  8. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

  1. History of sensitivity/idiosyncrasy to aprepitant or excipients
  2. Condition that might interfere with drug absorption, distribution metabolism or excretion.
  3. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
  4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
  6. Female subjects should not be pregnant or breast-feeding.
  7. Inadequate hematological function.
  8. Abnormal liver and renal function.
  9. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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): NCT02445872


Contacts
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Contact: Qiong Zhao, MD 0571-87236802 doczq.2008@gmail.com

Locations
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China, Zhejiang
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Qiong Zhao, MD The First Affiliated Hospital, Zhejiang University

Publications of Results:
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Responsible Party: Qiong Zhao, Chief, Department of Thoracic Oncology, Zhejiang University
ClinicalTrials.gov Identifier: NCT02445872     History of Changes
Other Study ID Numbers: ZYTOP1502
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: August 2015

Keywords provided by Qiong Zhao, Zhejiang University:
Nausea
Vomiting
Chemotherapy-induced Nausea and Vomiting
CINV
Aprepitant
Lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Nausea
Vomiting
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Cisplatin
Aprepitant
Fosaprepitant
Palonosetron
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