Clinical trial NCT00559455: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan
timeFrame: every 6 weeks
Secondary outcomes:
measure: Time to Progression (TTP), 6 month survival, overall survival, AFP
timeFrame: from the signature of Informed Consent up to end of the study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Hyang Rim Kim
role: STUDY_DIRECTOR
References: