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

NCT00559455 | Completed Phase 2

• 1 other identifier: OXALI_L_02859
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Progression (TTP), 6 month survival, overall survival, AFP

  from the signature of Informed Consent up to end of the study

Study Arms (1)

1

EXPERIMENTAL

Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin

Interventions

Oxaliplatin DRUG

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

1

Fluorouracil DRUG

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

1

Leucovorin DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• Documented allergy to platinum compound or to other study drugs.
• Active Gastro-Intestinal bleeding and active haematologic malignancy

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Hyang Rim Kim

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

KR (1)