Clinical trial · Interventional
Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma
NCT00483405CI-TRIAL-00028581NRRcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with cetuximab works in treating patients with advanced liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Trial
- description
- Single Arm Trial
- interventionNames
- Biological: cetuximab
- Drug: capecitabine
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Disease Response Rate
- timeFrame
- 42 days (2 cycles)
- description
- Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Histologically confirmed hepatocellular carcinoma * Alpha-fetoprotein (AFP) \> 400 ng/mL with compatible mass by CT scan or MRI * Metastatic disease OR not a candidate for surgical resection or immediate liver transplantation * At least 1 site of measurable disease OR evaluable disease (AFP 2 times upper limit of normal (ULN)) * No evidence of central nervous system (CNS) metastases (unless CNS metastases stable for \> 3 months) PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 3 times ULN * International normalized ratio (INR) ≤ 1.5 * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN * Creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to capecitabine, cetuximab, or oxaliplatin or to other murine products * No comorbid condition which is deemed by the investigator to have a life expectancy of \< 6 months * No New York Heart Association class III-IV coronary artery disease and/or heart failure * No variceal bleeding within the past 60 days * No other cancer within the past 5 years except cervical intraepithelial neoplasia, nonmelanoma skin cancer, ductal carcinoma in situ, chronic lymphocytic leukemia, or treated localized prostate cancer with a normal prostate specific antigen level * No active drug or alcohol abuse * No prior allergic reaction to a therapeutic antibody * No serious, uncontrolled infection * No history of uncontrolled seizures, CNS disorders, or psychiatric disability that, in the opinion of the investigator, would preclude study participation or compliance * No other serious uncontrolled medical condition that, in the opinion of the investigator, would preclude study participation * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No known existing uncontrolled coagulopathy PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior participation in an investigational drug trial * At least 4 weeks since prior major surgery and recovered * At least 4 weeks since prior embolization, resection, or ablation * No prior epidermal growth factor receptor (EGFR)-targeting therapy * No prior systemic chemotherapy or hepatic artery infusion of chemotherapy * No concurrent phenytoin * No concurrent therapeutic warfarin * Low-dose non-therapeutic warfarin to maintain patency of venous access devices allowed
References
Publications (1)
- RESULTSanoff HK, Bernard S, Goldberg RM, Morse MA, Garcia R, Woods L, Moore DT, O'Neil BH. Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab for Advanced Hepatocellular Carcinoma. Gastrointest Cancer Res. 2011 May;4(3):78-83. PMID 22043322