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Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

Phase 2
75 Years
Not Enrolling
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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.

Inclusion Criteria:

- Previously histologically confirmed aggressive lymphomas, defined according to WHO
classification (except Burkitt's lymphoma, lymphoblastic lymphoma)

- Failure to achieve a complete remission with the initial induction chemotherapy, or
recurrent disease

- Performance status (ECOG) ≤3

- Age ≤ 75

- Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen

- At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by
conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken)
or measurable lesion by physical examination

- Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul,
transaminases < 3 X upper normal values; bilirubin < 2 mg%

- Written informed consent approved by Institutional Review Board

Exclusion Criteria:

- Any other malignancies within the past 5 years except skin basal cell ca or CIS of

- Serious co-morbid diseases

- Pregnancy or breast-feeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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.

Outcome Time Frame:

up to 24 weeks

Safety Issue:


Principal Investigator

Cheolwon Suh, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:

AMC 2006-130



Start Date:

June 2006

Completion Date:

January 2008

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • oxaliplatin
  • refractory
  • relapsed
  • non-hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin