Colorectal NeoplasmsPhase 2NCT00044863
Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
A Phase 2 study testing Erbitux (Cetuximab) in people with Colorectal Neoplasms and Metastases, Neoplasm, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Metastases, Neoplasm
- What is being tested?
- Erbitux (Cetuximab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Dec 2005
- 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
- Provided signed written informed consent.
- Histologically- or pathologically- confirmed metastatic colorectal carcinoma;
- Documented progressive disease after receiving either:
- at least two chemotherapy regimens for metastatic disease or
- adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Progressive disease will be defined as progression while on treatment or within 3 months after receiving the last dose of therapy in a given regimen;
- Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine;
Show all 13Show fewer
- Measurable disease as defined in Section 3.3.2;
- Immunohistochemical evidence of EGFr expression. Patients will be considered eligible if their tumors demonstrate any EGFr staining, regardless of the intensity, the cellular localization of the staining, or the percentage of cell staining. Patients who do not have tumor tissue available for EGFr testing will undergo biopsy of accessible tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry;
- Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy;
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center;
- Men and woman age 18 years or older
- Source documentation of the prior treatment (e.g., hospital/clinic records, radiographic reports) must be available to ImClone for review.
Who cannot join
- Sex and Reproductive Status Exceptions
- Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to cetuximab administration.
- Sexually active fertile men not using effective birth control.
- Medical History and Concurrent Diseases
Show all 19Show fewer
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
- A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy;
- A history of uncontrolled angina, arrhythmias, congestive heart failure, or left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram (ECHO);
- Known brain metastases;
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for greater than or equal to 5 years will be allowed to enter the trial;
- Physical and Laboratory Test Findings
- Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL.
- Inadequate hepatic function, defined by a total bilirubin level greater than or equal to 1.5 times the upper limit of normal (ULN) and aspartate transaminase (AST) and alanine transaminase (ALT) levels greater than or equal to 5 times the ULN.
- Inadequate renal function defined by a serum creatinine level >1.5 times the ULN.
- Prohibited Therapies and/or Medications
- A history of cetuximab or other therapy that targeted the EGF receptor;
- A history of prior anti-cancer murine monoclonal antibody therapy;
- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
ImClone Investigational Site
Saint Charles, Missouri, 63301
About this study
Official title: A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must have documented failure after receiving either at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.
Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.
Read more
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.
In addition, there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the completion of the initial, fourth and sixth cetuximab infusions in the first course; and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy. A course of therapy is defined as six weekly infusions of cetuximab monotherapy. ImClone will perform the pharmacokinetic analyses.
- Conditions
- Colorectal Neoplasms, Metastases, Neoplasm
- Being tested
- Erbitux (Cetuximab)
- Keywords
- EGFr, Metastatic Colorectal Carcinoma
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbitux (Cetuximab)Biological
400 mg/m2 initial dose, 250 mg/m2 weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with metastatic EGFR-positive colorectal carcinoma Receives: Biological: Erbitux (Cetuximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the response rate of cetuximab in patients with EGFR-positive, metastatic carcinoma
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2002 (estimated)
- Study startAug 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044863
- Sponsor's protocol ID
- CP02-0144
- Status last verified
- Feb 2011
- First submitted
- 5 Sep 2002
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang W, Gordon M, Schultheis AM, Yang DY, Nagashima F, Azuma M, Chang HM, Borucka E, Lurje G, Sherrod AE, Iqbal S, Groshen S, Lenz HJ. FCGR2A and FCGR3A polymorphisms associated with clinical outcome of epidermal growth factor receptor expressing metastatic colorectal cancer patients treated with single-agent cetuximab. J Clin Oncol. 2007 Aug 20;25(24):3712-8. doi: 10.1200/JCO.2006.08.8021.
PubMed 17704420Lenz HJ, Van Cutsem E, Khambata-Ford S, Mayer RJ, Gold P, Stella P, Mirtsching B, Cohn AL, Pippas AW, Azarnia N, Tsuchihashi Z, Mauro DJ, Rowinsky EK. Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin, and fluoropyrimidines. J Clin Oncol. 2006 Oct 20;24(30):4914-21. doi: 10.1200/JCO.2006.06.7595.
PubMed 17050875Vallbohmer D, Zhang W, Gordon M, Yang DY, Yun J, Press OA, Rhodes KE, Sherrod AE, Iqbal S, Danenberg KD, Groshen S, Lenz HJ. Molecular determinants of cetuximab efficacy. J Clin Oncol. 2005 May 20;23(15):3536-44. doi: 10.1200/JCO.2005.09.100.
PubMed 15908664
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00044863
- Acronym / sponsor ID
- CP02-0144
- Conditions
- Colorectal Neoplasms, Metastases, Neoplasm
- Keywords
- EGFr, Metastatic Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 9 Sep 2002 (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.
This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must have documented failure after receiving either at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.
Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.
In addition, there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the completion of the initial, fourth and sixth cetuximab infusions in the first course; and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy. A course of therapy is defined as six weekly infusions of cetuximab monotherapy. ImClone will perform the pharmacokinetic analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Erbitux (Cetuximab)Patients with metastatic EGFR-positive colorectal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provided signed written informed consent.
- Histologically- or pathologically- confirmed metastatic colorectal carcinoma;
- Documented progressive disease after receiving either:
- Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine;
- Measurable disease as defined in Section 3.3.2;
Key exclusion criteria (19 listed)
- Sex and Reproductive Status Exceptions
- Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to cetuximab administration.
- Sexually active fertile men not using effective birth control.
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 |
|---|---|---|
| Erbitux (Cetuximab)400 mg/m2 initial dose, 250 mg/m2 weekly | Biological | 1 |
Primary outcome
Determine the response rate of cetuximab in patients with EGFR-positive, metastatic carcinoma
Time frame: every 6 months
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 23 Feb 2011.
- Results publication: PubMed 17704420Zhang W, Gordon M, Schultheis AM, Yang DY, Nagashima F, Azuma M, Chang HM, Borucka E, Lurje G, Sherrod AE, Iqbal S, Groshen S, Lenz HJ. FCGR2A and FCGR3A polymorphisms associated with clinical outcome of epidermal growth factor receptor expressing metastatic colorectal cancer patients treated with single-agent cetuximab. J Clin Oncol. 2007 Aug 20;25(24):3712-8. doi: 10.1200/JCO.2006.08.8021.
- Results publication: PubMed 17050875Lenz HJ, Van Cutsem E, Khambata-Ford S, Mayer RJ, Gold P, Stella P, Mirtsching B, Cohn AL, Pippas AW, Azarnia N, Tsuchihashi Z, Mauro DJ, Rowinsky EK. Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin, and fluoropyrimidines. J Clin Oncol. 2006 Oct 20;24(30):4914-21. doi: 10.1200/JCO.2006.06.7595.
- Results publication: PubMed 15908664Vallbohmer D, Zhang W, Gordon M, Yang DY, Yun J, Press OA, Rhodes KE, Sherrod AE, Iqbal S, Danenberg KD, Groshen S, Lenz HJ. Molecular determinants of cetuximab efficacy. J Clin Oncol. 2005 May 20;23(15):3536-44. doi: 10.1200/JCO.2005.09.100.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
E-mail: ClinicalTrials@ ImClone.com study chair
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erbitux (Cetuximab) in people with Colorectal Neoplasms and Metastases, Neoplasm, run by Eli Lilly and Company 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?
The sponsor lists 13 inclusion and 19 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 23 Feb 2011. 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?
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?
Determine the response rate of cetuximab in patients with EGFR-positive, metastatic carcinoma (time frame: every 6 months). 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 NCT00044863, which also lists 3 linked publications.
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 23 Feb 2011.