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Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin
Fluorouracil
Leucovorin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Lists of Inclusion and Exclusion criteria:

  • Patients must have histologically confirmed hepatocellular carcinoma
  • Patients must have measurable disease by CT scan
  • Have not received previous palliative systemic chemotherapy for metastatic disease. (Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)
  • Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 4 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
  • WHO 0-2 grades (Karnofsky Performance Score ≥ 70)

  • Patients must have adequate organ and marrow function:

    • Neutrophilus ≥ 1.5 x 10^9/L
    • Platelets ≥ 75 x 10^9/L
    • Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal Limit(UNL)
    • Total Bilirubin ≤ 1.5 x UNL
    • International Normalized Ratio < 1.5
    • Child stage A or B
    • Creatinine ≤ 1.5 X UNL

Exclusion Criteria:

  • Documented allergy to platinum compound or to other study drugs.
  • Active Gastro-Intestinal bleeding and active haematologic malignancy
  • Previous liver transplantation.
  • Patients concomitantly receiving any other anti-cancer therapy.
  • Patients who are receiving any other study treatments.
  • Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
  • History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  • Central nervous system metastasis
  • Other serious illness or medical conditions
  • Neuropathy ≥ grade 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan

Secondary Outcome Measures

Time to Progression (TTP), 6 month survival, overall survival, AFP

Full Information

First Posted
November 15, 2007
Last Updated
June 27, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00559455
Brief Title
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Official Title
Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objective: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV Secondary objective: To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
200mg/m², Day 1 and Day 2; Every 2 weeks
Primary Outcome Measure Information:
Title
Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan
Time Frame
every 6 weeks
Secondary Outcome Measure Information:
Title
Time to Progression (TTP), 6 month survival, overall survival, AFP
Time Frame
from the signature of Informed Consent up to end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Lists of Inclusion and Exclusion criteria: Patients must have histologically confirmed hepatocellular carcinoma Patients must have measurable disease by CT scan Have not received previous palliative systemic chemotherapy for metastatic disease. (Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.) Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 4 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion. WHO 0-2 grades (Karnofsky Performance Score ≥ 70) Patients must have adequate organ and marrow function: Neutrophilus ≥ 1.5 x 10^9/L Platelets ≥ 75 x 10^9/L Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal Limit(UNL) Total Bilirubin ≤ 1.5 x UNL International Normalized Ratio < 1.5 Child stage A or B Creatinine ≤ 1.5 X UNL Exclusion Criteria: Documented allergy to platinum compound or to other study drugs. Active Gastro-Intestinal bleeding and active haematologic malignancy Previous liver transplantation. Patients concomitantly receiving any other anti-cancer therapy. Patients who are receiving any other study treatments. Pregnant or lactating women or women of childbearing potential without proper contraceptive methods. History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. Central nervous system metastasis Other serious illness or medical conditions Neuropathy ≥ grade 2 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyang Rim Kim
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

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