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

NCT ID: NCT02445872

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-05-31

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting; Lung Cancer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

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

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Other Intervention Names

Emend

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief, Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Qiong Zhao, MD

Role: CONTACT

Phone: 0571-87236802

Email: doczq.2008@gmail.com

References

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.

Reference Type: RESULT

PMID: 22141732 (View on PubMed)

Other Identifiers

ZYTOP1502

Identifier Type: -

Identifier Source: org_study_id