Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer.

摘要: Pancreatic cancer is one of the most lethal and resistant to treatment solid tumors. Combination therapies with various types drugs against pancreatic have been extensively investigated. Endostatin a potent endog- enous inhibitor angiogenesis, which may be administered in combination chemotherapeutic agents several cancer. To best our knowledge, this phase I trial was first clinical study determine tolerance, safety efficacy M 2ES, novel polyethylene glycosylated recombinant human endostatin, concurrently full-dose gemcitabine patients inoperable, locally advanced or metastatic adenocarcinoma. A total 16 were treated (1,000 mgm 2 on days 1, 8 15) M2ES (5-45 8, 15 21) each 28-day cycle. In evaluable patients, stable disease rate (SDR) 40% (95% CI: 11.9-68.1%). particular, 75% SDR observed 3 out 4 dose level 7.5 mg/m . The noticeable M2ES-related adverse events during grade liver function abnormalities (6.3%) 1 skin rash (6.3%). No dose-limiting toxicity any from all levels. Therefore, there no increased associated addition well tolerated.