Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter

NCT ID: NCT00250822

Last Updated: 2011-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-07-31

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 100,000 per microliter in a single arme Phase II trial.

To determine the toxicity profile of this regimen To determine the effect of this treatment on patient survival, time to treatment failure, time ot progression, time to response.

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 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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gemcitabine and Oxaliplatin

Dose:

Gemcitabine 1000 mg/m2 - IV in about 60 minutes on days 1 & 15. Oxaliplatin 100 mg/m2 - IV over 2hr on days 2 & 16

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehuda Patt, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

Hematology Oncology Associates

Albuquerque, New Mexico, United States

Lovelace Sandia Health Systems Dept of Hematology

Albuquerque, New Mexico, United States

University of New Mexico

Albuquerque, New Mexico, United States

St. Vincent Regional Medical Center

Santa Fe, New Mexico, United States

Countries

United States

Other Identifiers

INST 0521C

Identifier Type: -

Identifier Source: org_study_id