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

Lead Sponsor: China Medical University, China

Collaborator: 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

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.

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).

• Neoplasms

Intervention Type: Drug

Intervention Name: Thalidomide

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: Placebo for thalidomide

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: Palonosetron and Dexamethasone

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.

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

China

August 2016

Type: Principal Investigator

Investigator Affiliation: China Medical University, China

Investigator Full Name: Yunpeng Liu

Investigator Title: M.D.,PhD

• solid tumor
• chemotherapy-induced delayed nausea and vomiting
• thalidomide
• prevention

• Nausea
• Vomiting

Label: Thalidomide 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.

Label: Placebo 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.

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)