Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant improvements in overall survival (OS), progression-free survival (PFS), as well as response rate (RR), in patients with previously untreated metastatic non small cell lung cancer (NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced colorectal cancer. The investigators carried out a phase II trial to investigate the activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
200mg/m2 iv d1 ,repeat every 14 days
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
Cancer hospital & Institute,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGresponse rate
From date of treatment was administered until the date of first documented response according to RECIST criteria
Time frame: 3 years
progression free survival
From date of chemotherapy was administered until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8 weeks.
Time frame: 3 years
overall survival
From date of treatment was administered until the date of death from any cause, assessed every 3 months.
Time frame: 3 years
Number of participants with adverse events
assessed from the date of treatment to 1 month after stop treatment
Time frame: 3 years
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