efficacy of thalidomide in preventing chemotherapy-induced delayed nausea and vomiting

Conditions: Neoplasms

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.

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 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

Keywords: solid tumor chemotherapy-induced delayed nausea and vomiting thalidomide prevention