Colorectal CancerPhase 2NCT01004159
Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan
A Phase 2 study testing cetuximab with irinotecan in people with Colorectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cetuximab with irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2012
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colon cancer that is metastatic or unresectable
- Progressed on cetuximab plus irinotecan based combination prior to enrolling on this study
- Patient must have tumor tissue tested for KRAS mutation and should be confirmed to carry a wild type
- ECOG less than or equal to 1
- Must have adequate organ and marrow function
- Ability to understand and the willingness to sign a written informed consent document.
- Presence of measurable disease defined as a lesion ≥ 2 cm by CT (or 1 cm by spiral CT). All sites of disease should be evaluated ≤ 3 weeks before treatment initiation
- Patients should have failed or been deemed intolerant to other standard chemotherapy treatments such as oxaliplatin and fluoropyrimidines
Who cannot join
- Patients may not be receiving any other investigational agents that are not included in this study. Prior investigational anticancer agents wil not be allowed within 4 weeks prior to study treatment. Herbal medicine and vitamins wil not be considered as contraindications for enrollment on study.
- Patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology
- History of other invasive cancers with current evidence of disease
- Patients should be off chemotherapy or other targeted therapies for at least 3 weeks before study treatment. Mitomycin C treatment should be at least 6 weeks before study treatment
- History of allergic reactions to irinotecan
- Prior severe infusion reaction to cetuximab
Show all 12Show fewer
- History of allergic reaction to tetracycline or doxycycline
- Need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity
- Active skin toxicity of grade 2 or higher at the time of study enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the chemotherapeutic agents proposed are category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated on this study.
- Grade 2 or higher hypomagnesemia at baseline evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan
This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer
Read the detailed description
Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating in your blood stream. The growth of colorectal cancer may be affected by the interaction of a growth factor known as "epidermal growth factor" (EGF) with its receptor.
Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off the activity of the receptor and to stop the growth of cancer cells in many laboratory tests. Cetuximab has been recently approved by the Food and Drug Administration in the treatment of patients with advanced colorectal cancer and who failed standard chemotherapy. Cetuximab has been shown to delay the progression of colorectal cancer when given alone in patients who have failed standard chemotherapy and when given with a chemotherapy drug called irinotecan in patients who have failed irinotecan.
- Conditions
- Colorectal Cancer
- Being tested
- cetuximab with irinotecan
- Keywords
- Colorectal cancer, KRAS wild type tumors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximab with irinotecanDrug
Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
| Study group | Role | What they receive |
|---|---|---|
| cetuximab with irinotecan | Experimental | Not described Receives: Drug: cetuximab with irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer
Measured: 12 week
Secondary outcomes (1)
Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: former PI left institute
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 Roswell Park Cancer InstituteThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- WenWee Ma, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004159
- Sponsor's protocol ID
- I 152009
- Status last verified
- Sep 2015
- First submitted
- 28 Oct 2009
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan
- ClinicalTrials.gov ID
- NCT01004159
- Acronym / sponsor ID
- I 152009
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, KRAS wild type tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: former PI left institute
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Posted 16 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer
Detailed description
Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating in your blood stream. The growth of colorectal cancer may be affected by the interaction of a growth factor known as "epidermal growth factor" (EGF) with its receptor.
Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off the activity of the receptor and to stop the growth of cancer cells in many laboratory tests. Cetuximab has been recently approved by the Food and Drug Administration in the treatment of patients with advanced colorectal cancer and who failed standard chemotherapy. Cetuximab has been shown to delay the progression of colorectal cancer when given alone in patients who have failed standard chemotherapy and when given with a chemotherapy drug called irinotecan in patients who have failed irinotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab with irinotecan | Experimental | Drug: cetuximab with irinotecan |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed colon cancer that is metastatic or unresectable
- Progressed on cetuximab plus irinotecan based combination prior to enrolling on this study
- Patient must have tumor tissue tested for KRAS mutation and should be confirmed to carry a wild type
- ECOG less than or equal to 1
- Must have adequate organ and marrow function
Key exclusion criteria (12 listed)
- Patients may not be receiving any other investigational agents that are not included in this study. Prior investigational anticancer agents wil not be allowed within 4 weeks prior to study treatment. Herbal medicine and vitamins wil not be considered as contraindications for enrollment on study.
- Patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology
- History of other invasive cancers with current evidence of disease
- Patients should be off chemotherapy or other targeted therapies for at least 3 weeks before study treatment. Mitomycin C treatment should be at least 6 weeks before study treatment
- History of allergic reactions to irinotecan
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 with irinotecanCetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment | Drug | cetuximab with irinotecan |
Primary outcome
12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer
Time frame: 12 week
1 secondary outcome
Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- 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.
WenWee Ma, MD principal investigator
Roswell Park Cancer Institute
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 cetuximab with irinotecan in people with Colorectal Cancer, run by Roswell Park Cancer Institute 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 19 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 16 May 2014). 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?
12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer (time frame: 12 week). 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 19 Oct 2015.