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

NCT00250822 | Completed Phase 2 DMC

• 1 other identifier: INST 0521C
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

Liver Cancer

Keywords

Liver; hepatocellular; Gem-Ox; Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Cycles will be repeated every 4 weeks until disease progression.

Interventions

Gemcitabine and Oxaliplatin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (4)

Hematology Oncology Associates

Albuquerque, New Mexico, 87102-3661, United States

Location

Lovelace Sandia Health Systems Dept of Hematology

Albuquerque, New Mexico, 87108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

St. Vincent Regional Medical Center

Santa Fe, New Mexico, 87505, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Yehuda Patt, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: October 5, 2011

Record last verified: 2011-09

Locations

US (4)