search
Back to results

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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine and Oxaliplatin
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Liver, hepatocellular, Gem-Ox, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hematology Oncology Associates
  • Lovelace Sandia Health Systems Dept of Hematology
  • University of New Mexico
  • St. Vincent Regional Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2005
Last Updated
September 23, 2011
Sponsor
New Mexico Cancer Care Alliance
search

1. Study Identification

Unique Protocol Identification Number
NCT00250822
Brief Title
Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Liver, hepatocellular, Gem-Ox, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine and Oxaliplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
Cycles will be repeated every 4 weeks until disease progression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Patt, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-3661
Country
United States
Facility Name
Lovelace Sandia Health Systems Dept of Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
St. Vincent Regional Medical Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs