The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a pragmatic randomized, multi-center, open-label randomized clinical trial, aimed to evaluate efficacy and safety of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after multi-cycle cisplatin-containing highly emetogenic chemotherapy (HEC) .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yunpeng Liu
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone acetate; Palonosetron; Serotonin 5-HT3 Receptor Antagonists; Thalidomide

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;the patients and their couples should receive contraception for at least 3 years after their last dosage of thalidomide.

• Cancer patients scheduled to receive chemotherapy containing a 50 mg/m2 or higher dose of cisplatin for 4-6 cycles

Exclusion Criteria:

• Diabetic patients

• Pregnant or lactated women

• Patient with history of severe thrombosis

• Concomitant radiotherapy

• Known hypersensitivity yo 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

• Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (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