Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy
considered curable in many cases. However, diagnosis of refractory or relapsed disease is
devastating and the treatment is difficult because regimens of chemotherapy used as salvage
therapy are available only in limited numbers. ESHAP, consisting of etoposide,
methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage
regimen, and showed its efficacy and feasibility. But it often requires discontinuation of
the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also
impede further treatment. Oxaliplatin, a platinum coordination complex with an
oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher
cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be
active in patients with NHL as a single agent. In addition, the substitution of cisplatin by
oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL,
showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical
and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which
substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and
toxicity profile in patients with recurrent or refractory NHL.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
up to 24 weeks
No
Cheolwon Suh, MD, PhD
Principal Investigator
Asan Medical Center
Korea: Food and Drug Administration
AMC 2006-130
NCT00336583
June 2006
January 2008
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