Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer
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.
Drug: Endostatins (Endostar)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer|
- response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of first documented response according to RECIST criteria
- progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of death from any cause, assessed every 3 months.
- Number of participants with adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]assessed from the date of treatment to 1 month after stop treatment
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Drug: Endostatins (Endostar)
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
Other Name: EndostarDrug: Oxaliplatin
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
Other Name: EloxatinDrug: Leucovorin
200mg/m2 iv d1 ,repeat every 14 daysDrug: 5-fluorouracil
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
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.
|Contact: Wen Zhang, MDemail@example.com|
|Contact: Lin Yang, MDfirstname.lastname@example.org|
|Cancer hospital & Institute,Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Wen Zhang, MD 86-10-87788145 email@example.com|
|Contact: Lin Yang, MD 86-10-87788118 firstname.lastname@example.org|
|Principal Investigator: Lin Yang, MD|
|Principal Investigator:||Lin Yang, MD||Cancer hospital&institute,Chinese Academy of Medical Sciences|