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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Fluorouracil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559455

OXALI_L_02859

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.