Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203253
• Other study ID #: CLOG1302
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2014
• Last updated: August 23, 2016
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Neoplasms
• Vomiting

Intervention

Drug:
• Thalidomide
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
• Placebo for thalidomide
Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
• Palonosetron and Dexamethasone
Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.

Locations

Country	Name	City	State
China	Anshan Tumor Hospital	Anshan	Liaoning
China	Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Hospital of Liaoning Medical University	Jinzhou	Liaoning
China	Liaoyang Central Hospital	Liaoyang	Liaoning
China	Petrochemical General Hospital of Liaoyang city	Liaoyang	Liaoning
China	Third People's hospital Liaoyang	Liaoyang	Liaoning
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (11)

Lead Sponsor

Collaborator

China Medical University, China

Anshan Tumor Hospital, General Hospital of Shenyang Military Region, Liaoning Tumor Hospital & Institute, Liaoyang Central Hospital, Petrochemical General Hospital of Liaoyang city, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Liaoning Medical University, The Second Affiliated Hospital of Dalian Medical University, Third People's hospital Liaoyang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate (CRR) for delayed CINV		120 hours	No
Secondary	Adverse Events		Up to 3 weeks	Yes
Secondary	quality of life		up to 7 days	No