Hepatocellular CarcinomaPhase 2NCT00142428
Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
A Phase 2 study testing Cetuximab in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable or metastatic hepatocellular carcinoma
- Measurable tumor
- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7 x upper limit of normal (ULN).
- Adequate renal function: serum creatinine < 2.0mg/dl
- Adequate bone marrow function: absolute neutrophil count (ANC) > 1,000/mm3; platelets > 75,000/mm3.
- 0-2 prior systemic chemotherapy regimens for hepatocellular carcinoma
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- 18 years of age and older
- ECOG performance status of 0-2
- Life expectancy > 12 weeks
Who cannot join
- Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry
- Uncontrolled serious medical or psychiatric illness
- Irradiation or chemotherapy for disease within 28 days of study entry
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Received an investigational agent within 30 days
- Cancer of the Liver Italian Program (CLIP) score > 3
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- Acute hepatitis
- Active or uncontrolled infection
- Significant history of cardiac disease
- Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma.
Read the detailed description
The first step in this study is to examine the tumor biopsy (previously collected) and determine whether or not it is epidermal growth factor receptor (EGFR) positive or EGFR negative. Both EGFR positive and EGFR negative patients can participate in this study because at this time it is not known whether having a negative or positive receptor makes a difference in how the study drug works on the tumor. By knowing if the tumor is EGFR positive or negative, we will be able to see if there is a difference in the way the tumor responds to cetuximab.
Patients will receive cetuximab intravenously once weekly for 6 weeks. Each 6-week period is one cycle of treatment. The first dose of cetuximab is larger than the following doses.
For the first clinic visit the patient's blood pressure, temperature, breathing and heart rate will be taken before, during, at the end, and one-hour after the cetuximab has been administered. For each visit after that, blood pressure, temperature, breathing and heart rate will be taken before and after cetuximab has been administered.
Before each administration of cetuximab, diphenhydramine will also be administered to decrease the chances of an allergic or hypersensitivity reaction.
The following tests and procedures will be performed at weeks 1, 3 and 5 during each 6-week cycle of treatments as well as at the end of study treatment: physical exam, vital signs, medical history and blood work. At the end of each 6-week cycle a CT and/or MRI will be performed to measure the tumor size.
Long-term follow-up will include physical exams and bloodwork every 6 months.
Patients will remain on cetuximab as long as there is no disease progression or intolerable side effects.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cetuximab
- Keywords
- Hepatocellular carcinoma, cetuximab, Unresectable hepatocellular carcinoma, Metastatic hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Experimental | The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks. Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival in patients treated with cetuximab for unresectable or metastatic hepatocellular carcinoma
Measured: 2 years
Secondary outcomes (3)
Number of patients with adverse events
Measured: 2 years
Overall Survival
Measured: 2 years
Objective Response Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionOct 2005
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Bristol-Myers Squibb
- Responsible party
- Principal investigator, Andrew X. Zhu, MD, Massachusetts General Hospital
- Investigators
- Andrew X. Zhu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142428
- Sponsor's protocol ID
- 04-347
- Status last verified
- Mar 2014
- First submitted
- 31 Aug 2005
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00142428
- Acronym / sponsor ID
- 04-347
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, cetuximab, Unresectable hepatocellular carcinoma, Metastatic hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Bristol-Myers Squibb
- Study start
- Jan 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma.
Detailed description
The first step in this study is to examine the tumor biopsy (previously collected) and determine whether or not it is epidermal growth factor receptor (EGFR) positive or EGFR negative. Both EGFR positive and EGFR negative patients can participate in this study because at this time it is not known whether having a negative or positive receptor makes a difference in how the study drug works on the tumor. By knowing if the tumor is EGFR positive or negative, we will be able to see if there is a difference in the way the tumor responds to cetuximab.
Patients will receive cetuximab intravenously once weekly for 6 weeks. Each 6-week period is one cycle of treatment. The first dose of cetuximab is larger than the following doses.
For the first clinic visit the patient's blood pressure, temperature, breathing and heart rate will be taken before, during, at the end, and one-hour after the cetuximab has been administered. For each visit after that, blood pressure, temperature, breathing and heart rate will be taken before and after cetuximab has been administered.
Before each administration of cetuximab, diphenhydramine will also be administered to decrease the chances of an allergic or hypersensitivity reaction.
The following tests and procedures will be performed at weeks 1, 3 and 5 during each 6-week cycle of treatments as well as at the end of study treatment: physical exam, vital signs, medical history and blood work. At the end of each 6-week cycle a CT and/or MRI will be performed to measure the tumor size.
Long-term follow-up will include physical exams and bloodwork every 6 months.
Patients will remain on cetuximab as long as there is no disease progression or intolerable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Experimental | Drug: CetuximabThe initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Unresectable or metastatic hepatocellular carcinoma
- Measurable tumor
- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7 x upper limit of normal (ULN).
- Adequate renal function: serum creatinine < 2.0mg/dl
- Adequate bone marrow function: absolute neutrophil count (ANC) > 1,000/mm3; platelets > 75,000/mm3.
Key exclusion criteria (11 listed)
- Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry
- Uncontrolled serious medical or psychiatric illness
- Irradiation or chemotherapy for disease within 28 days of study entry
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Received an investigational agent within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabThe initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks. | Drug | Cetuximab |
Primary outcome
Progression free survival in patients treated with cetuximab for unresectable or metastatic hepatocellular carcinoma
Time frame: 2 years
3 secondary outcomes
Number of patients with adverse events
Time frame: 2 years
Overall Survival
Time frame: 2 years
Objective Response Rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew X. Zhu, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 3 sites 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?
The sponsor lists 9 inclusion and 11 exclusion criteria. 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival in patients treated with cetuximab for unresectable or metastatic hepatocellular carcinoma (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2014.