Clinical trial NCT02203253: Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Official title: Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Keywords: solid tumor
chemotherapy-induced delayed nausea and vomiting
thalidomide
prevention
Lead sponsor: China Medical University, China
Sponsor class: OTHER
Collaborators: name: The First Hospital of Liaoning Medical University
name: The First Affiliated Hospital of Dalian Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: Liaoning Cancer Hospital & Institute
name: Shengjing Hospital
name: General Hospital of Shenyang Military Region
name: Liaoyang Central Hospital
name: Third People's hospital Liaoyang
name: Petrochemical General Hospital of Liaoyang city
name: Anshan Tumor Hospital
First posted: 2014-07-29
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.

Detailed description: This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL).

Eligibility criteria: Inclusion Criteria:

* 18y ≤Age≤70y
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Histologically confirmed solid neoplasm
* No prior chemotherapy
* Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
* Life expectancy of at least 12 weeks
* Signed informed consent
* For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
* Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin

Exclusion Criteria:

* Diabetic patients
* Pregnant or lactated women
* Patient with history of thrombosis
* Concomitant radiotherapy
* Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.
* Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs
* CHOP regiment or taxanes-based regiment
* Existing emesis within 24 hours before chemotherapy administration
* Symptomatic brain metastasis or suspected clinical brain metastasis
* Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
* Inability to take or absorb oral medicine
* Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
* Unsuitable for the study or other chemotherapy determined by investigator

Primary outcomes:
measure: complete response rate (CRR) for delayed CINV
timeFrame: 120 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 3 weeks
measure: quality of life
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Anshan
country: China
facility: Anshan Tumor Hospital
state: Liaoning
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The First Hospital of Liaoning Medical University
state: Liaoning
city: Liaoyang
country: China
facility: Liaoyang Central Hospital
state: Liaoning
city: Liaoyang
country: China
facility: Petrochemical General Hospital of Liaoyang city
state: Liaoning
city: Liaoyang
country: China
facility: Third People's hospital Liaoyang
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Tumor Hospital & Institute
state: Liaoning
Study officials:
affiliation: China Medical University, China
name: Yunpeng Liu, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: