Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer

NCT00483405 | Completed Phase 2 Results DMC

• 3 other identifiers: LCCC 0421KL2RR0257465K23CA118431-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Cancer

Keywords

advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease Response Rate

  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.

  42 days (2 cycles)

Secondary Outcomes (3)

• Number of Subjects Experiencing Adverse Events

  every 3 weeks of treatment with an average of 15 weeks on treatment

• Overall Survival

  Median 23 month follow-up

• Time to Progression

  Median 23 month follow-up

Study Arms (1)

Single Arm Trial

OTHER

Single Arm Trial

Biological: cetuximab; Drug: capecitabine; Drug: oxaliplatin

Interventions

cetuximab BIOLOGICAL

250 mg/m2, intravenously, once per week

Also known as: Erbitux

Single Arm Trial

capecitabine DRUG

850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.

Also known as: Xeloda

Single Arm Trial

oxaliplatin DRUG

130 mg/m2, intravenously on Day 1 of each 21 day cycle

Also known as: Eloxatin

Single Arm Trial

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Sanofi: collaborator
• Roche Pharma AG: collaborator
• Bristol-Myers Squibb: collaborator
• National Center for Research Resources (NCRR): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (1)

• Sanoff 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 RESULT

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Cetuximab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

robin_v_johnson@med.unc.edu

919-966-1125

Study Officials

• Bert H. O'Neil, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Michael A. Morse, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: October 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 12, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)