Colorectal CarcinomaPhase 2NCT00215722
XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Cetuximab in people with Colorectal Carcinoma, run by Grupo de Investigacao do Cancro Digestivo at 10 sites in Portugal.
Trial summary
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Cetuximab
- How many people
- 45 participants
- Where
- 10 sitesPortugal
- Study dates
- Jul 2005to Jul 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
- Signed written informed consent, prior any study-specific procedures
- Male or female > = 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease not eligible for surgery with curative intent - in case of a unique metastatic lesion this should be confirmed by biopsy
- ECOG performance status < 1 at study entry
- Immunohistochemical evidence of EGFR expression on tumour tissue
- Presence of at least one unidimensional measurable lesion with a diameter > 20mm by conventional CT scan or MRI, and 10mm by spiral CT scan, according to the RECIST criteria (Index lesion(s) must not lie within an irradiated area)
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- Have not received any Chemotherapy regimen for metastatic disease
- Life expectancy of > 3 months
- Neutrophils > = 1.5 x 109/L, platelet count > = 100 x 109/L, and haemoglobin > = 9 g/dL.
- Bilirubin level either normal or 1.5 x ULN
- ASAT and ALAT < = 2.5 x ULN (< = 5 x ULN in case of liver metastasis)
- Alkaline phosphatase < = 2.5 x ULN or < = 5 x ULN in case of liver metastasis or < = 10 x ULN in case of bone metastases
- Serum creatinine < = 1.5 x ULN or CrCl > 50 ml/min (Cockroft and Gault formula)
- Negative Pregnancy test within one week before treatment start, if applicable
Who cannot join
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan.
- Adjuvant or neo-adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months and the patient have not progressed during treatment
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
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- Previous exposure to EGFR-pathway targeting therapy
- History of evidence upon physical examination of CNS disease (e.g. primary brain tumour, seizure not controlled with standard therapy, any brain metastasis or history of stroke)
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- Pre-existing neuropathy > grade 1
- Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- 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 > = 5 years will be allowed to enter the trial)
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Pregnant or lactating women
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
- Known dihydropyrimidine dehydrogenase deficiency
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Portugal10 sites
Hospital Garcia de Orta
Almada, 2800
Hospital Distrital do Barreiro
Barreiro, 2830
Hospital Distrital de Beja
Beja, 7800-309
Hospital de São Marcos
Braga, 4700
Hospitais da Universidade de Coimbra
Coimbra, 3000-075
IPO - Coimbra
Coimbra, 3000
Centro Hospitalar do Funchal
Funchal, 9000-514
Hospital Pedro Hispano
Matosinhos Municipality, 4454-509
Hospital do Divino Espírito Santo
Ponta Delgada, 9500-370
IPO - Porto
Porto, 4200
About this study
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.
Read the detailed description
The phase II trials with XELOX, demonstrated that is a highly effective first-line treatment for metastatic colorectal cancer, with response rates similar to the regimens with oxaliplatin and infusional 5-FU/LV (FOLFOX), but more convenient and likely to be preferred by both patients and health care providers.
Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease which suggests that a much greater degree of benefit may ensue when it is used at an earlier stage of the disease course.
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.
- Conditions
- Colorectal Carcinoma
- Being tested
- Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Efficacy of the combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy based on the overall response rate (ORR) according to the RECIST criteria.
Secondary outcomes (4)
Determine the Safety parameters of combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy analyzing the frequency, severity, duration and relationship of adverse events using the NCI CTCAE, version 3.0
Time to tumour progression (TTP)
Overall survival time (OS)
Evaluate the Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Grupo de Investigacao do Cancro Digestivo
- Sponsor type
- University, hospital or other
- Investigators
- Evaristo Sanches, MD, Principal investigator, Grupo de Investigação do Cancro DigestivoSérgio Barroso, MD, Principal investigator, Grupo de Investigação do Cancro Digestivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215722
- Sponsor's protocol ID
- GICR-P003
- Status last verified
- Apr 2007
- First submitted
- 20 Sep 2005
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00215722
- Acronym / sponsor ID
- GICR-P003
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Grupo de Investigacao do Cancro DigestivoUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jul 2008 (estimated)
- First posted
- 22 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 first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.
Detailed description
The phase II trials with XELOX, demonstrated that is a highly effective first-line treatment for metastatic colorectal cancer, with response rates similar to the regimens with oxaliplatin and infusional 5-FU/LV (FOLFOX), but more convenient and likely to be preferred by both patients and health care providers.
Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease which suggests that a much greater degree of benefit may ensue when it is used at an earlier stage of the disease course.
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent, prior any study-specific procedures
- Male or female > = 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease not eligible for surgery with curative intent - in case of a unique metastatic lesion this should be confirmed by biopsy
- ECOG performance status < 1 at study entry
- Immunohistochemical evidence of EGFR expression on tumour tissue
Key exclusion criteria (21 listed)
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan.
- Adjuvant or neo-adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months and the patient have not progressed during treatment
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
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 | Drug | – |
Primary outcome
Determine the Efficacy of the combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy based on the overall response rate (ORR) according to the RECIST criteria.
4 secondary outcomes
Determine the Safety parameters of combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy analyzing the frequency, severity, duration and relationship of adverse events using the NCI CTCAE, version 3.0
Time to tumour progression (TTP)
Overall survival time (OS)
Evaluate the Quality of Life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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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.
Evaristo Sanches, MD principal investigator
Grupo de Investigação do Cancro Digestivo
Sérgio Barroso, MD principal investigator
Grupo de Investigação do Cancro Digestivo
10 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 Colorectal Carcinoma, run by Grupo de Investigacao do Cancro Digestivo at 10 sites in Portugal.
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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal. 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?
Results are not available in the source record.
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 Efficacy of the combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy based on the overall response rate (ORR) according to the RECIST criteria.. 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 6 Apr 2007.