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

China Medical University, China

Status and phase: Completed; Phase 3

Conditions: Neoplasms

Treatments: Drug: Thalidomide; Drug: Placebo for thalidomide; Drug: Palonosetron and Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02203253

CLOG1302

Details and patient eligibility

About

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.

Full 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).

Enrollment: 642 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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642 participants in 2 patient groups, including a placebo group

Thalidomide Group

Active Comparator group

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.

Treatment:

Drug: Thalidomide

Drug: Palonosetron and Dexamethasone

Placebo Group

Placebo Comparator group

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.

Treatment:

Drug: Placebo for thalidomide

Drug: Palonosetron and Dexamethasone