Multicenter, Double-blinding, Randomized Controlled, Phase II Clinical Trial on Combined Chemotherapy of Endostar (Recombinant Human Endostatin) for Untreated Patients With Advanced Melanoma
Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and as a
single agent gives a response rate of about 20%. There have been efforts to ameliorate this
poor result by using DTIC in different combinations without a significant improvement. In
addition, new studies with melanoma cells in vitro show that DTIC combination with Endostar,
suggesting a potential clinical benefit from the concomitant treatment of DTIC and
antiangiogenesis therapy. Endostar is a wild spectrum and safe antiangiogenesis factor which
could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent
human genome. The purpose of this study is to determine whether a combination therapy of
endostar and DTIC is safe and can increase response rate and progression-free survival in
patients (pts) with metastatic melanoma. We will evaluate the efficacy and safety of the
Endostar plus DTIC and hope provide a new hope for the advanced melanoma patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival time , Total survival time
2010.8
No
Guo Jun, PI
Principal Investigator
Expert Committee for Melanoma of CSCO
China: Ethics Committee
simcere001
NCT00813449
August 2008
August 2010
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