Status:
COMPLETED
Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the primary end point response rate of the combinations of Gemcitabine and Oxaliplatin (Gem-Ox) in the treatment of hepatocellular carcinoma (HCC) in patients with platelet counts greater...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Patients with symptomatic brain metastases that had not been adequately and definitively treated with radiation and/or surgical resection are excluded from this study.
- 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 Participation.
- Evidence of inadequately treated CNS metastases.
- Major surgery within 4 weeks of the s1art of the study treatment without complete recovery.
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00250822
Start Date
October 1 2005
End Date
July 1 2006
Last Update
October 5 2011
Active Locations (4)
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1
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87102-3661
2
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States, 87108
3
University of New Mexico
Albuquerque, New Mexico, United States, 87131
4
St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505