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

NCT02445872 | Unknown Phase 2

• 1 other identifier: ZYTOP1502
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  5 days after the end of chemotherapy

Secondary Outcomes (4)

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

  5 days after the end of chemotherapy

• Emesis-free

  5 days after the end of chemotherapy

• Presence of nausea

  5 days after the end of chemotherapy

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

  5 days after the end of chemotherapy

Study Arms (2)

Arm A

EXPERIMENTAL

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; Drug: Palonosetron; Drug: Dexamethasone

Arm B

ACTIVE COMPARATOR

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

Interventions

Aprepitant 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

Also known as: Emend

Arm A

Palonosetron DRUG

Arm A; Arm B

Dexamethasone DRUG

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• 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.

  PMID: 22141732 RESULT

MeSH Terms

Conditions

Vomiting; Lung Neoplasms; Nausea

Interventions

Aprepitant; Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Qiong Zhao, MD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiong Zhao, MD

CONTACT

0571-87236802; doczq.2008@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Thoracic Oncology

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 9, 2015

Record last verified: 2015-08

Locations

CN (1)