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Liver CancerPhase 2NRRNCT00483405

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

A Phase 2 study testing cetuximab, capecitabine and oxaliplatin in people with Liver Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Liver Cancer
What is being tested?
cetuximab, capecitabine and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Oct 2006to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599-7295

Other trials in United States

About this study

Official title: Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the response rate in patients with advanced hepatocellular carcinoma and hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.

Secondary

  • Determine the safety of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the time to tumor progression in patients treated with this regimen.

OUTLINE: This is an open label, nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120 minutes on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3 months thereafter.

Conditions
Liver Cancer
Keywords
advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    Also called Erbitux

    250 mg/m2, intravenously, once per week

  • capecitabineDrug

    Also called Xeloda

    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.

  • oxaliplatinDrug

    Also called Eloxatin

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

Study groups in NCT00483405
Study groupRoleWhat they receive
Single Arm TrialOtherSingle Arm Trial
Receives: Biological: cetuximab; Drug: capecitabine; Drug: oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 42 days (2 cycles)

Secondary outcomes (3)

  1. Number of Subjects Experiencing Adverse Events

    Adverse events will be assessed using CTCAE criteria.

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

  2. Overall Survival

    Overall survival will be calculated from time of enrollment to death or last contact date.

    Measured: Median 23 month follow-up

  3. Time to Progression

    Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Median 23 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionFeb 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00483405
Sponsor's protocol ID
LCCC 0421
Other IDs
KL2RR025746, 5K23CA118431-02
Acronym
NRR
Status last verified
Jun 2017
First submitted
6 Jun 2007
Last updated
12 Jul 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22043322

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, capecitabine and oxaliplatin in people with Liver Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Response Rate (time frame: 42 days (2 cycles)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00483405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.

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