Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Hepatocellular
Intervention: Oxaliplatin (Drug); Fluorouracil (Drug); Leucovorin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Hyang Rim Kim, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
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
Clinical Details
Official title: Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: 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: Time to Progression (TTP), 6 month survival, overall survival, AFP
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Lists of Inclusion and Exclusion criteria:
Inclusion Criteria:
- Patients must have histologically confirmed hepatocellular carcinoma
- Patients must have measurable disease by CT scan
- Patients with unresectable, recurrent or metastatic disease may be chemonaive or may
be previously treated by chemotherapy.
- The period of Washout of prior chemotherapy must be greater than 4 weeks from date of
randomization. The prior chemotherapy should not include platinum compounds.
- WHO (World Health Organization) performance status: 0 to 2
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/μl
- Platelets ≥80,000/μl
- Total bilirubin < 3. 0g/dl
- ASAT/ALAT/AKP ≤ 3 times the upper normal limits of the institute
- Creatinine < 120μmol/l
Exclusion Criteria:
- Documented allergy to platinum compound or to others study's drugs
- Pregnant or lactating women or women of childbearing potential (e. g. not using
adequate contraception)
- Active gastrointestinal bleeding or hematological disorder or other malignancies,
except cured basal cell carcinoma of skin and cured carcinoma in- situ of uterine
cervix.
- Metastasis to central nervous system
- Other serious illness or medical conditions
- Concurrent treatment with any other anticancer therapy
- Concurrent treatment with other experimental drugs.
- Patients received TACE (TransArterial ChemoEmbolization) more than 3 times
- neuropathy ≥ Grade 2
- Liver transplantation patient
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
Sanofi-aventis, Seoul, Korea, Republic of; Recruiting
Additional Information
Starting date: September 2007
Last updated: June 23, 2008
|
