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

Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559455

Enrollment

Registered

2007-11-16

Start date

2007-09-30

Completion date

2010-01-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

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

Interventions

DRUGOxaliplatin

85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks

DRUGFluorouracil

400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks

DRUGLeucovorin

200mg/m², Day 1 and Day 2; Every 2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan	every 6 weeks

Secondary

Measure	Time frame
Time to Progression (TTP), 6 month survival, overall survival, AFP	from the signature of Informed Consent up to end of the study

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026