A Single Center, Non-randomized Phase IIa Study of Abraxane in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in
southern and southeastern China, where the incidence rate has been documented between 10 and
150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy
remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel
([Abraxane, ABX ];Celgene,Summit,NJ) is a promising new agent with more efficient entry to
the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by
cancer cells. Superior activity of ABX-based regimens without the necessity for
antianaphylactic pretreatments been shown in various solid tumors compared with the
traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of
combination of ABX and cisplatin (DDP) has not been determined in patients with advanced
NPC. In this single center, non-randomized phase IIa study, investigators seek to determine
the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an
exploratory study of its efficacy as measured by tumor response.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR)
24 months
Yes
Li Zhang, MD
Principal Investigator
Sun Yat-sen University
China: Food and Drug Administration
ABXDDP20101224
NCT01735409
November 2012
August 2013
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