Clinical trial NCT02445872: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lung Cancer
Keywords: Nausea
Vomiting
Chemotherapy-induced Nausea and Vomiting
CINV
Aprepitant
Lung cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Complete Response
timeFrame: 5 days after the end of chemotherapy
Secondary outcomes:
measure: Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea)
timeFrame: 5 days after the end of chemotherapy
measure: Emesis-free
timeFrame: 5 days after the end of chemotherapy
measure: Presence of nausea
timeFrame: 5 days after the end of chemotherapy
measure: Safety and tolerability (adverse events related to study drug administration)
timeFrame: 5 days after the end of chemotherapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Qiong Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.