Colorectal CancerPhase 1NCT00820417
Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib
A Phase 1 study testing Cetuximab/Gefitinib combination and/or monotherapy in people with Colorectal Cancer and Head and Neck Cancer, run by Harrison Clinical Research at 2 sites in 2 countries.
Trial summary
This is an open-label, phase 1, non-randomised, non-controlled trial, carried out in two centres on patients with advanced cancer expressing EGFR. Primary objective is the determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the combination of intravenous Cetuximab and oral Gefitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Head and Neck Cancer, Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Cetuximab/Gefitinib combination and/or monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2004to May 2008
- Phase
- Phase 1
- 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
- Written informed consent prior to inclusion
- Confirmed histological diagnosis of non-resectable, solid, malignant, EGFR expressing tumours of the following types: colorectal cancer, head and neck cancer and non-small cell lung cancer (NSCLC). Advanced clinical stage III/IV which did not respond to standard therapy or for which no suitable therapy exists
- Patients with at least one evaluable lesion (evaluable disease) by the RECIST criteria
- Availability of tumour tissue, whether from primary tumour or metastasis to determine EGFR expression
- Viability of establishing outpatient treatment
- Effective contraception for patients of both sexes if there is a risk of conception
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- Karnofsky performance status greater than 70 %
- Life expectancy > 12 weeks
- Adequate renal function (creatinine < 1.5 x UNL), liver function (bilirubin < 1.5 x UNL, ALT/AST < 2.5 x UNL o <5 x UNL if hepatic metastasis) and adequate bone marrow (leucocytes > 3000/µl, absolute neutrophil count > 1500/µl, platelets > 100,000/µl, haemoglobin > 9 g/dl)
- Patients must not have undergone chemotherapy, radiotherapy or major surgery during the 3 weeks before the beginning of the study, and they must have recovered from the relevant secondary effects of previous treatments
- Patients agree to have a new biopsy after two weeks.
Who cannot join
- Patients with any symptom of bowel obstruction and/or inflammatory bowel disease
- Previous therapy with anti-EGFR drugs
- Patients with known cerebral metastasis
- Patients with known active and uncontrolled infections
- Severe uncontrolled organic dysfunctions or metabolic disorders
- Patients unable to give informed consent
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- Patients who do not wish to or who cannot undergo the specific study treatments and the study procedures
- Pregnancy or breastfeeding
- Patient participation in another clinical trial during the previous 30 days
- Patients with known drug and/or alcohol abuse
- Known hypersensitivity to chimeric MoAbs or pretreatment with MoAbs
- Any other malignant tumour in the last two years or previously diagnosed malignant tumour if there is no guarantee that it is under complete control, except for suitably treated in situ cervical carcinoma or basocellular carcinoma
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not to be excluded)
- Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase 1 Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of the Combination of Cetuximab (C-225), a Chimeric Monoclonal Antibody Against the Epidermal Growth Factor Receptor (EGFR), and Gefitinib (ZD1839), a Selective EGFR Tyrosine Kinase Inhibitor, in Patients With Advanced Cancer
This is an open-label, phase 1, non-randomised, non-controlled trial, carried out in two centres on patients with advanced cancer expressing EGFR. Primary objective is the determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the combination of intravenous Cetuximab and oral Gefitinib.
Read the detailed description
Between 36 and 66 patients will be enrolled depending on the number of dose levels which can be completed. Patients will have histologically confirmed EFGR-expressing solid malignant tumours (colorectal cancer, head and neck cancer and NSCLC), which did not respond to standard therapy or for which no suitable therapy exists.
- Being tested
- Cetuximab/Gefitinib combination and/or monotherapy
- Keywords
- cetuximab, monoclonal, antibody, epidermal, growth, factor, receptor, EGFR, Gefitinib, tyrosine, kinase, inhibitor, advanced, cancer
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab/Gefitinib combination and/or monotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | Dose-escalation Receives: Drug: Cetuximab/Gefitinib combination and/or monotherapy |
| B | Experimental | Maximum tolerated dose (MTD) Receives: Drug: Cetuximab/Gefitinib combination and/or monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of the combination intravenous Cetuximab/oral Gefitinib.
Secondary outcomes (5)
To determine the pharmacokinetic (PK) parameters of the combination Cetuximab/Gefitinib
To determine the pharmacogenomic profile of study patients and to correlate the different profiles with efficacy
To determine the possible correlation between activity and the polymorphisms of the EGFR measured in the blood and in the primary tumour
To assess the possible immune response related to cetuximab
To estimate signs of clinical activity (response rate according to the RECIST criteria)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 1
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harrison Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820417
- Sponsor's protocol ID
- C-225/ZD1839
- Status last verified
- Jan 2009
- First submitted
- 9 Jan 2009
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of the Combination of Cetuximab (C-225), a Chimeric Monoclonal Antibody Against the Epidermal Growth Factor Receptor (EGFR), and Gefitinib (ZD1839), a Selective EGFR Tyrosine Kinase Inhibitor, in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00820417
- Acronym / sponsor ID
- C-225/ZD1839
- Keywords
- cetuximab, monoclonal, antibody, epidermal, growth, factor, receptor, EGFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Harrison Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, AstraZeneca
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Jan 2009 (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 an open-label, phase 1, non-randomised, non-controlled trial, carried out in two centres on patients with advanced cancer expressing EGFR. Primary objective is the determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the combination of intravenous Cetuximab and oral Gefitinib.
Detailed description
Between 36 and 66 patients will be enrolled depending on the number of dose levels which can be completed. Patients will have histologically confirmed EFGR-expressing solid malignant tumours (colorectal cancer, head and neck cancer and NSCLC), which did not respond to standard therapy or for which no suitable therapy exists.
Study design
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Drug: Cetuximab/Gefitinib combination and/or monotherapyDose-escalation |
| B | Experimental | Drug: Cetuximab/Gefitinib combination and/or monotherapyMaximum tolerated dose (MTD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent prior to inclusion
- Confirmed histological diagnosis of non-resectable, solid, malignant, EGFR expressing tumours of the following types: colorectal cancer, head and neck cancer and non-small cell lung cancer (NSCLC). Advanced clinical stage III/IV which did not respond to standard therapy or for which no suitable therapy exists
- Patients with at least one evaluable lesion (evaluable disease) by the RECIST criteria
- Availability of tumour tissue, whether from primary tumour or metastasis to determine EGFR expression
- Viability of establishing outpatient treatment
Key exclusion criteria (16 listed)
- Patients with any symptom of bowel obstruction and/or inflammatory bowel disease
- Previous therapy with anti-EGFR drugs
- Patients with known cerebral metastasis
- Patients with known active and uncontrolled infections
- Severe uncontrolled organic dysfunctions or metabolic disorders
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 |
|---|---|---|
| Cetuximab/Gefitinib combination and/or monotherapy | Drug | B, a |
Primary outcome
The primary objective of the study is to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of the combination intravenous Cetuximab/oral Gefitinib.
5 secondary outcomes
To determine the pharmacokinetic (PK) parameters of the combination Cetuximab/Gefitinib
To determine the pharmacogenomic profile of study patients and to correlate the different profiles with efficacy
To determine the possible correlation between activity and the polymorphisms of the EGFR measured in the blood and in the primary tumour
To assess the possible immune response related to cetuximab
To estimate signs of clinical activity (response rate according to the RECIST criteria)
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 12 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab/Gefitinib combination and/or monotherapy in people with Colorectal Cancer and Head and Neck Cancer, run by Harrison Clinical Research at 2 sites in 2 countries.
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 11 inclusion and 16 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 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary objective of the study is to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of the combination intravenous Cetuximab/oral Gefitinib.. 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 12 Jan 2009.