Phase â…  Clinical Trial Of7Days On/14Days Off Capecitabine In Combination With Docetaxel And Oxaliplatin In The Treatment Of Advanced Malignant Solid Tumors

Objective The combination of Docetaxel,Cisplatin and5-Fluorouracil (DCF) have been confirmed to be effective for various malignant solid tumors, such as gastric cancer, esophagus cancer, head and neck metastatic squamous cell carcinoma, while at the cost of serious adverse events which might be reduced with the replacement of cisplatin and infusional5-fluorouracil by oxaliplatin and capecitabine respectively. Shortening the exposure time of capecitabine from14days to7days in a21-day cycle might lead to a better tolerability. we conducted this phase I clinical trial inpatients with various malignant solid tumors with the combination of docetaxel, oxaliplatin and7days on/14days off capecitabine (DOC), to find out the dose-limiting toxicity and the recommending dose for phase II clinical trial. Methods In patients with advanced disease, Zubrod-ECOG-WHO performance status of0～1, adequate liver and kidney fuction were required. Docetaxel (65mg/m,75mg/m2) and oxaliplatin (80mg/m2,100mg/m2,120mg/m2,130mg/m2) were administered intravenously on day1, and capecitabine (750mg/m2,1000mg/m2,1250mg/m2, 1500mg/m2,twice daily) was taken orally from day1to day7in a21-day cycle. We escalated the dose of docetaxel,oxaliplatin and capecitabine in a standard three-patients-per-corhort dose-escalation schedule. Result A total of9patients was recruited into the trial from Oct2009to Apr2012, including4patients with nasopharyngeal carcinoma,4patients with gastric cancer and1patient with neck metastatic squamous cell carcinoma. Dose-limiting toxicities of this DOC regimen were grade4neutropenia,grade2febrile neutropenia, grade3vomit and apocleisis, the efficacy was promising with response rate44.44%, desease control rate66.67%, and the Maximum tolerated dose(MTD) was docetaxel,75mg/m2, d1, oxaliplatin100mg/m2, d1, capecitabine1000mg/m2twice, d1-7, repeated every21days. Conclusion The combination of docetaxel,75mg/m2, dl, oxaliplatin100mg/m2, dl, capecitabine,1000mg/m2, bid, d1-7, repeated every21days, is well tolerant and merit further investigation in phase Ⅱ trial.