Spots Global Cancer Trial Database for Recombinant Human Endostatin in Combination With mFOLFOX6 in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Recombinant Human Endostatin in Combination With mFOLFOX6 in Patients With Metastatic Colorectal Cancer
Official Title: PhaseⅠClinical Study of Recombinant Human Endostatin in Combination With mFOLFOX6 as Initial Therapy for Patients With Metastatic Colorectal Cancer
Study ID: NCT01310478
Conditions
Interventions
Study Description
Brief Summary: To investigate safety and tolerance of dose-escalation of infusional recombinant human endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic colorectal cancer.
Detailed Description: Recombinant human endostatin(Endostar) is commonly used through intermittent intravenous adminstration in routine clinical practice in China. It is very difficult to maintain steady-state of plasma concentration of this agent due to this manner of application. Continous infusional Endostar was designed to alter the imblance of concentration to avoid compromising efficacy of anti-angionesis therapy.The strategy of dose-escalation was used in this study in order to obtain the optimal dosage of Endostar for the next phase Ⅱ trial.
Eligibility
Minimum Age: 17 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Jin Li, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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