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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559455
• Other study ID #: OXALI_L_02859
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: June 27, 2011
• Start date: September 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Oxaliplatin
85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
• Fluorouracil
400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks
• Leucovorin
200mg/m², Day 1 and Day 2; Every 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Progression (TTP), 6 month survival, overall survival, AFP		from the signature of Informed Consent up to end of the study	No