Colorectal CancerPhase 2NCT00444678
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
A Phase 2 study testing Cetuximab, Oxaliplatin and Capecitabine in people with Colorectal Cancer and Neoplasm Metastasis, run by NYU Langone Health at 2 sites in United States.
Trial summary
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis
- What is being tested?
- Cetuximab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2004to 1 Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have signed an approved informed consent.
- Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis.
- No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant therapy with 5FU/LV or IFL (irinotecan, fluorouracilis, and leucovorin (folinic acid)) permitted if completed at least six months prior to entering this study.
- Measurable disease by RECIST criteria as defined in Section 3.3.1.
- Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing for EGFR expression.
- ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1.
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- Recovery in full from any previous surgical procedure.
- Expected survival greater than 12 weeks.
- Subjects at least 18 years of age.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
- Adequate hematologic function defined by an absolute neutrophil count (ANC) > 1,500/mm3, a platelet count > 100,000/mm3 .
- Adequate hepatic function defined by a total bilirubin level no greater than 2.0 times the upper limit of normal (ULN) and AST (Aspartate Aminotransferase) and ALT (alanine transaminase) levels noo greater than 2.5 times the ULN (AST and ALT levels no greater than 5 times the ULN in the presence of liver metastases).
- Adequate renal function defined by a serum creatinine level no greater than 1.5 times the ULN.
Who cannot join
- 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 study drug administration.
- Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.
- Subjects with > Grade 1 neuropathy.
- Any active or uncontrolled infection.
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- History of myocardial infarction within the previous six months or current clinical evidence of congestive heart failure.
- History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
- Central nervous system metastases.
- Pregnant or lactating women. Men and women of reproductive potential must agree to use an effective contraceptive method.
- Medical or psychiatric disorders that would interfere with informed consent or make them a poor risk for participation in this trial.
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
- Subjects receiving a prior investigational agent within 30 days.
- Prior therapy with oxaliplatin, cetuximab, or prior therapy that targets the EGF ( epidermal growth factor) pathway.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
- Mutation in the KRAS gene
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital
New York, New York, 10016
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin (C-CO2) in the Treatment of Patients With KRAS Wild Type Metastatic Colorectal Cancer
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.
Read the detailed description
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV (fluorouracil/leucovorin) in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a chimeric monoclonal antibody against the growth factor receptor, has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone. Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx (capecitabine plus oxaliplatin) regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- Cetuximab, Oxaliplatin, Capecitabine
- Keywords
- Previously untreated metastatic colorectal cancer, Metastatic Colorectal Cancer, combined therapy, biologics therapy, antibody, chemotherapy, EGFR, epidermal growth factor receptor
- 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.
CetuximabDrug
Also called Erbitux, C225
500 mg/m2, IV every two weeks
OxaliplatinDrug
Also called Eloxatin
85 mg/m2, IV, q 2 weeks
CapecitabineDrug
Also called Xeloda
2500 mg, po bid x 7 days every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | Experimental | Not described Receives: Drug: Cetuximab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate for the Combination Treatment
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
Measured: 6 months since the start of treatment
Secondary outcomes (3)
Toxicity Rates
# of subjects who experienced >= grade 1 adverse event that is positively related to treatment.
Measured: 1 year since the first treatment and every year after for up to 10 years
Time to Progression
Time to Treatment Failure (progression or death) will be defined as the time from the first day of treatment until the date Progressive Disease (PD) or death is first reported. Subjects who die without a reported prior progression will be considered to have progressed on the day of their death. Subjects who did not progress will be censored at the day of their last tumor assessment.
Measured: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Survival
Survival will be defined as the number of days from the first day of therapy to the date of death. If the subject is lost to follow-up, survival will be censored on the last date the subject was known to be alive.
Measured: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study start1 Jun 2004
- Primary completion1 Aug 2012
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Deirdre Cohen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444678
- Sponsor's protocol ID
- NYU# 04-10 H11817
- Other IDs
- CA225056
- Status last verified
- Apr 2020
- First submitted
- 7 Mar 2007
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin (C-CO2) in the Treatment of Patients With KRAS Wild Type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00444678
- Acronym / sponsor ID
- NYU# 04-10 H11817
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- Previously untreated metastatic colorectal cancer, Metastatic Colorectal Cancer, combined therapy, biologics therapy, antibody, chemotherapy, EGFR, epidermal growth factor receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Study start
- 1 Jun 2004
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 3 Apr 2020
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, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.
Detailed description
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV (fluorouracil/leucovorin) in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a chimeric monoclonal antibody against the growth factor receptor, has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone. Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx (capecitabine plus oxaliplatin) regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | Experimental | Drug: Cetuximab, Drug: Oxaliplatin, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must have signed an approved informed consent.
- Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis.
- No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant therapy with 5FU/LV or IFL (irinotecan, fluorouracilis, and leucovorin (folinic acid)) permitted if completed at least six months prior to entering this study.
- Measurable disease by RECIST criteria as defined in Section 3.3.1.
- Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing for EGFR expression.
Key exclusion criteria (16 listed)
- 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 study drug administration.
- Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.
- Subjects with > Grade 1 neuropathy.
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 |
|---|---|---|
| CetuximabAlso: Erbitux, C225500 mg/m2, IV every two weeks | Drug | Cetuximab, Capecitabine and Oxaliplatin |
| OxaliplatinAlso: Eloxatin85 mg/m2, IV, q 2 weeks | Drug | Cetuximab, Capecitabine and Oxaliplatin |
| CapecitabineAlso: Xeloda2500 mg, po bid x 7 days every two weeks | Drug | Cetuximab, Capecitabine and Oxaliplatin |
Primary outcome
Response Rate for the Combination Treatment
Time frame: 6 months since the start of treatment
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
3 secondary outcomes
Toxicity Rates
Time frame: 1 year since the first treatment and every year after for up to 10 years
Time to Progression
Time frame: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Survival
Time frame: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deirdre Cohen, MD principal investigator
NYU Langone Health
2 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, Oxaliplatin and Capecitabine in people with Colorectal Cancer and Neoplasm Metastasis, run by NYU Langone Health at 2 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 13 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 3 Apr 2020. 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 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 3 Apr 2020). 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?
Response Rate for the Combination Treatment (time frame: 6 months since the start of treatment). 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 3 Apr 2020.