Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Information source: China Medical University, China
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms
Intervention: Thalidomide (Drug); Placebo for thalidomide (Drug); Palonosetron and Dexamethasone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: China Medical University, China Official(s) and/or principal investigator(s): Yunpeng Liu, MD., PhD, Principal Investigator, Affiliation: China Medical University, China
Overall contact: Yunpeng Liu, MD.,PhD, Phone: +86-24-83282312, Email: cmuliuyunpeng@hotmail.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: complete response rate (CRR) for delayed CINV
Secondary outcome: Adverse Eventsquality of life
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Yunpeng Liu, MD.,PhD, Phone: +86-24-83282312, Email: cmuliuyunpeng@hotmail.com
Anshan Tumor Hospital, Anshan, Liaoning, China; Not yet recruiting Li zhong Zhou, Principal Investigator
Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China; Not yet recruiting
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China; Not yet recruiting
The First Hospital of Liaoning Medical University, Jinzhou, Liaoning, China; Not yet recruiting
Liaoyang Central Hospital, Liaoyang, Liaoning, China; Not yet recruiting
Petrochemical General Hospital of Liaoyang city, Liaoyang, Liaoning, China; Not yet recruiting Jingyan wang, Principal Investigator
Third People's hospital Liaoyang, Liaoyang, Liaoning, China; Not yet recruiting
General Hospital of Shenyang Military Region, Shenyang, Liaoning, China; Not yet recruiting Xiaodong Xie, Principal Investigator
Liaoning Tumor Hospital & Institute, Shenyang, Liaoning, China; Not yet recruiting Tao Sun, Principal Investigator Xiaoling Li, Principal Investigator Rui Ma, Principal Investigator Weijun Ma, Principal Investigator
Shengjing Hospital of China Medical University, Shenyang, Liaoning 110004, China; Not yet recruiting
The First Hospital of China Medical University, Shenyang, Liaoning 110001, China; Recruiting Yunpeng Liu, MD., PhD, Phone: 86-24-83282312, Email: cmuliuyunpeng@hotmail.com Yunpeng Liu, MD., PhD., Principal Investigator
Additional Information
Starting date: July 2014
Last updated: July 27, 2014
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