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
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Sponsors
Lead Sponsor
Collaborators
The First Hospital of Liaoning Medical University 
, The First Affiliated Hospital of Dalian Medical University , The Second Affiliated Hospital of Dalian Medical University , Liaoning Tumor Hospital & Institute , Shengjing Hospital , General Hospital of Shenyang Military Region , Liaoyang Central Hospital , Third People's hospital Liaoyang , Petrochemical General Hospital of Liaoyang city , Anshan Tumor Hospital
, The First Affiliated Hospital of Dalian Medical University , The Second Affiliated Hospital of Dalian Medical University , Liaoning Tumor Hospital & Institute , Shengjing Hospital , General Hospital of Shenyang Military Region , Liaoyang Central Hospital , Third People's hospital Liaoyang , Petrochemical General Hospital of Liaoyang city , Anshan Tumor Hospital Source
China Medical University, China
Oversight Info
Has Dmc
No
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).
Overall Status
Completed
Start Date
2014-07-01
Completion Date
2016-08-01
Primary Completion Date
2016-07-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
complete response rate (CRR) for delayed CINV |
120 hours |
Secondary Outcome
Measure |
Time Frame |
|
Adverse Events |
Up to 3 weeks |
|
quality of life |
up to 7 days |
Enrollment
642
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
Arm Group Label
Thalidomide Group
Intervention Type
Drug
Intervention Name
Description
Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
Arm Group Label
Placebo Group
Other Name
Placebo tablet for thalidomide
Intervention Type
Drug
Intervention Name
Description
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.
Arm Group Label
Thalidomide Group
Placebo Group
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
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Yunpeng Liu, MD., PhD |
Principal Investigator |
China Medical University, China |
Location
Facility |
|
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 |
|
The First Hospital of China Medical University Shenyang Liaoning 110001 China |
|
Shengjing Hospital of China Medical University Shenyang Liaoning 110004 China |
|
General Hospital of Shenyang Military Region Shenyang Liaoning China |
|
Liaoning Tumor Hospital & Institute Shenyang Liaoning China |
Location Countries
Country
China
Verification Date
2016-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
China Medical University, China
Investigator Full Name
Yunpeng Liu
Investigator Title
M.D.,PhD
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Thalidomide
Dexamethasone
Dexamethasone acetate
Palonosetron
BB 1101
Arm Group
Arm Group Label
Thalidomide Group
Arm Group Type
Active Comparator
Description
Thalidomide 100 mg by mouth twice a day on days 1-5; 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.
Arm Group Label
Placebo Group
Arm Group Type
Placebo Comparator
Description
Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; 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.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)
Study First Submitted
July 23, 2014
Study First Submitted Qc
July 27, 2014
Study First Posted
July 29, 2014
Last Update Submitted
August 23, 2016
Last Update Submitted Qc
August 23, 2016
Last Update Posted
August 24, 2016
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.