Chemotherapy-Induced Nausea and Vomiting, Lung Cancer
Conditions
Keywords
Nausea, Vomiting, Chemotherapy-induced Nausea and Vomiting, CINV, Aprepitant, Lung cancer
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.
Interventions
DRUGAprepitant
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
DRUGPalonosetron
DRUGDexamethasone
Sponsors
Merck Sharp & Dohme LLC
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of nausea | 5 days after the end of chemotherapy | Presence of nausea graded according to Likert scale (none, mild, moderate and severe) |
| Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea) | 5 days after the end of chemotherapy | No emetic episode, no need for rescue medication, with a maximum grade of mild nausea |
| Emesis-free | 5 days after the end of chemotherapy | Percentage of patients without emetic episodes |
| Safety and tolerability (adverse events related to study drug administration) | 5 days after the end of chemotherapy | Number of patients experienced at least one adverse events related to study drug administration. |
Countries
China
Contacts
Primary ContactQiong Zhao, MD
Outcome results
None listed