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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 Events

quality 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

Page last updated: August 23, 2015

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