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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250822
First received: November 4, 2005
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: Gemcitabine and Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

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. [ Time Frame: Cycles will be repeated every 4 weeks until disease progression. ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250822

Locations
United States, New Mexico
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87102-3661
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States, 87108
University of New Mexico
Albuquerque, New Mexico, United States, 87131
St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Yehuda Patt, MD University of New Mexico
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00250822     History of Changes
Other Study ID Numbers: INST 0521C
Study First Received: November 4, 2005
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Liver
hepatocellular
Gem-Ox
Cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Gemcitabine
Oxaliplatin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014