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Single Arm, Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin (GEM-OX) for Hepatocellular Carcinoma (HCC) Patients With Platelet Counts Greater Than 100,000 Per Microliter.

Phase 2
18 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

Single Arm, Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin (GEM-OX) for Hepatocellular Carcinoma (HCC) Patients With Platelet Counts Greater Than 100,000 Per Microliter.

The treatment plan is a two-step design. Day 1 the pt will receive Gemcitabine IV and Day 2
the pt will receive Oxaliplatin IV. This treatment cycle is repeated approximately every 28
days. Subsequent treatment cycle dosages are based on toxicity diaries and lab work
results. CT scans are repeated every 2 treatment cycles. Continuation in the study is
dependent upon tumor response.

Inclusion Criteria:

- All patients 18 years of age or older, with hepatocellular carcinoma are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a ECOG performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

- There must be one measurable lesion according to the RECIST criteria that should not
have had prior radiation treatment.

Exclusion Criteria:

- Patients with symptomatic brain metastases that had not been adequately and
definitively treated with radiation and/or surgical resection are excluded from this

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Life expectancy of less than 12 weeks.

- Serious, uncontrolled concurrent infection(s)

- Any prior treatment with, Gemcitabine or Oxaliplatin .

- Completion of previous chemotherapy regimen less than 4 weeks, prior to start of this
study or persistence of prior treatment related toxicity.

- Treatment for other carcinomas within the last five years, except for cured
non-melanoma of the skin and treated in-situ cervical cancer.

- Participation in any investigational study within 4 weeks preceding the start of the
study treatment.

- Clinically significant heart disease defined as NYHA class 3 or 4 heart disease.

- Chronic debilitating diseases that the investigator feels might compromise the study

- Evidence of inadequately treated CNS metastases.

- Major surgery within 4 weeks of the s1art of the study treatment without complete

- Known or existing uncontrolled coagulopathy.

- Any of the following laboratory parameters v) Abnormal hematological values with ANC
less than 1500/mm3, thrombocytopenia less than 99,000. vi) Impaired renal function
with a serum creatinine of greater than 1.5 ULN vii) Serum bilirubin greater than
1.5xULN viii) Albumin less than 2.5mg/dl.

- Unwillingness to give informed consent.

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate ( CR + PR rate); namely, to determine response rate to the Gemcitabine and Oxaliplatin combination administered to patients with hepatocellular cancer. Furthermore, patients who achieve a response leading to tumor respectability.

Outcome Time Frame:

Cycles will be repeated every 4 weeks until disease progression.

Safety Issue:


Principal Investigator

Yehuda Patt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

INST 0521C



Start Date:

October 2005

Completion Date:

July 2006

Related Keywords:

  • Liver Cancer
  • Liver
  • hepatocellular
  • Gem-Ox
  • Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



University of New MexicoAlbuquerque, New Mexico  87131
Hematology Oncology AssociatesAlbuquerque, New Mexico  87106
Lovelace Sandia Health Systems Dept of HematologyAlbuquerque, New Mexico  87108
St. Vincent Regional Medical CenterSanta Fe, New Mexico  87505