NCT02203253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
642

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 23, 2014

Last Update Submit

August 23, 2016

Conditions

Neoplasms

Keywords

solid tumorchemotherapy-induced delayed nausea and vomitingthalidomideprevention

Outcome Measures

Primary Outcomes (1)

  • complete response rate (CRR) for delayed CINV

    120 hours

Secondary Outcomes (2)

  • Adverse Events

    Up to 3 weeks

  • quality of life

    up to 7 days

Study Arms (2)

Thalidomide Group

ACTIVE COMPARATOR

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.

Drug: ThalidomideDrug: Palonosetron and Dexamethasone

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo for thalidomideDrug: Palonosetron and Dexamethasone

Interventions

ThalidomideDRUG

100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1

Thalidomide Group
Placebo for thalidomideDRUG

Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1

Also known as: Placebo tablet for thalidomide
Placebo Group
Palonosetron and DexamethasoneDRUG

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.

Placebo GroupThalidomide Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y ≤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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Anshan Tumor Hospital

Anshan, Liaoning, China

Location

Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First Hospital of Liaoning Medical University

Jinzhou, Liaoning, China

Location

Liaoyang Central Hospital

Liaoyang, Liaoning, China

Location

Petrochemical General Hospital of Liaoyang city

Liaoyang, Liaoning, China

Location

Third People's hospital Liaoyang

Liaoyang, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Location

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

NeoplasmsVomiting

Interventions

ThalidomidePalonosetronDexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinuclidinesHeterocyclic Compounds, Bridged-RingIsoquinolinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Yunpeng Liu, MD., PhD

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,PhD

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 29, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

CN(11)