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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting, Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Aprepitant

Palonosetron

Dexamethasone

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Nausea and Vomiting focused on measuring Nausea, Vomiting, Chemotherapy-induced Nausea and Vomiting, CINV, Aprepitant, Lung cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

History of sensitivity/idiosyncrasy to aprepitant or excipients
Condition that might interfere with drug absorption, distribution metabolism or excretion.
Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
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).
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
Female subjects should not be pregnant or breast-feeding.
Inadequate hematological function.
Abnormal liver and renal function.
Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Sites / Locations

The first affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Complete Response

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

Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea)

No emetic episode, no need for rescue medication, with a maximum grade of mild nausea

Emesis-free

Percentage of patients without emetic episodes

Presence of nausea

Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

Safety and tolerability (adverse events related to study drug administration)

Number of patients experienced at least one adverse events related to study drug administration.

Full Information

NCT ID

NCT02445872

First Posted

April 5, 2015

Last Updated

December 8, 2015

Sponsor

Zhejiang University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02445872

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-Induced Nausea and Vomiting, Lung Cancer

Keywords

Nausea, Vomiting, Chemotherapy-induced Nausea and Vomiting, CINV, Aprepitant, Lung cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

Emend

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Primary Outcome Measure Information:

Title

Complete Response

Description

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

Time Frame

5 days after the end of chemotherapy

Secondary Outcome Measure Information:

Title

Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea)

Description

No emetic episode, no need for rescue medication, with a maximum grade of mild nausea

Time Frame

5 days after the end of chemotherapy

Title

Emesis-free

Description

Percentage of patients without emetic episodes

Time Frame

5 days after the end of chemotherapy

Title

Presence of nausea

Description

Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

Time Frame

5 days after the end of chemotherapy

Title

Safety and tolerability (adverse events related to study drug administration)

Description

Number of patients experienced at least one adverse events related to study drug administration.

Time Frame

5 days after the end of chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient who was confirmed lung cancer by pathologic histology or cytology. Males or females aged ≥18 years, <80 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. Patients with asymptomatic, treated brain metastases are eligible for trial participation. Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment. Exclusion Criteria: History of sensitivity/idiosyncrasy to aprepitant or excipients Condition that might interfere with drug absorption, distribution metabolism or excretion. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics 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). Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. Female subjects should not be pregnant or breast-feeding. Inadequate hematological function. Abnormal liver and renal function. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qiong Zhao, MD

Phone

0571-87236802

doczq.2008@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiong Zhao, MD

Organizational Affiliation

The First Affiliated Hospital, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22141732

Citation

Gao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x.

Results Reference

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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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