Colorectal CancerPhase 2NCT00493857
Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer
A Phase 2 study testing Nimotuzumab Humanized Monoclonal Antibody and Nimotuzumab in people with Colorectal Cancer, run by YM BioSciences at 12 sites in Canada.
Trial summary
This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan. The study will test: How long any good effects last. How bad any side effects are. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nimotuzumab Humanized Monoclonal Antibody and Nimotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesCanada
- Study dates
- Jun 2007to Dec 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
- Confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies.
- Measurable disease,
- Must have clinical documentation of failure after receiving at least one chemotherapy regimen for metastatic disease that contained irinotecan.
- Must have documentation of failure by CT, MRI or PET scan. Patients who were intolerant of irinotecan despite dose attenuations are not eligible for this trial.
- Patients must have failed irinotecan which they received on one of the following three starting regimens:Weekly,Biweekly or every 3 weeks. mg/m2.
- 6.Patients may have received any number of prior standard and investigational regimens or radiation treatments, provided that they meet all other eligibility criteria.
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- Age greater than 18 years.
- Life expectancy of greater than 3 months.
- ECOG performance status less than 1
- Patients must have normal organ and marrow function
- Patients must have medical documentation of dose, schedule, and dates of last irinotecan administration.
- Women of child-bearing potential and men must agree to use adequate contraception
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Subject Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have recovered to < grade 2.
- No other investigational agents.
- No known brain metastases.Patients with a history of primary CNS tumours, seizures not well controlled with standard medical therapy, or history of stroke will also be excluded.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to nimotuzumab, irinotecan, or other agents used in the study.
- Previous EGFR-directed therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled hypertension, clinically significant cardiac arrhythmia, history of myocardial infarction within the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible
- Active cardiovascular disease, e.g., uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medications, or grade II or greater peripheral vascular disease. In addition, patients with arterial thrombosis, myocardial infarction, and cerebral vascular accidents [stroke/transient ischemic attack (TIA)] within 6 months prior to study entry will be excluded.
- Organ allografts requiring immunosuppressive therapy. -.Pregnant or lactating women are excluded from this study.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Grand River Hospital
Kitchener, Ontario, N2G 1G3
London Regional Cancer Centre
London, Ontario, N6A 4L6
Credit Valley Hospital /Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1
Cancer Care Program Southlake Regional Health Centre
Newmarket, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Algoma District Cancer Care Program
Sault Ste. Marie, Ontario, P6A 2C4
Dr. H. Bliss Purphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan.
The study will test:
Read more
- How long any good effects last.
- How bad any side effects are.
Objectives:
Primary:
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Secondary:
- To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;
- To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules;
- To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules;
- To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules;
- To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules;
- To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;
- To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety;
- To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab;
- To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.
Read the detailed description
The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.
- Conditions
- Colorectal Cancer
- Being tested
- Nimotuzumab Humanized Monoclonal Antibody, Nimotuzumab
- Keywords
- Colorectal cancer, Monoclonal antibody, Anti-EGFR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab Humanized Monoclonal AntibodyDrug
Nimotuzumab 400mg every week
NimotuzumabDrug
Nimotuzumab 400mg every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Nimotuzumab 400mg every week or every two weeks Receives: Drug: Nimotuzumab Humanized Monoclonal Antibody; Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Measured: 18-24 months
Secondary outcomes (1)
Assess the incidence of acneiform rash,drug reaction,adverse events, the assessment of progression-free survival,stable disease,time to disease progression, overall survival, objective response rates, safety and trough levels in the serum of patients.
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionDec 2008 (estimated)
Why it stopped: Cohort 2 not going forward. Manadate changes in Company
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amil Shah, MD, Study chair, Vancouver Cancer Centre BC cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493857
- Sponsor's protocol ID
- YMB 1000-015
- Status last verified
- Nov 2008
- First submitted
- 27 Jun 2007
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00493857
- Acronym / sponsor ID
- YMB 1000-015
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Monoclonal antibody, Anti-EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cohort 2 not going forward. Manadate changes in Company
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 28 Jun 2007 (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 study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan.
The study will test:
- How long any good effects last.
- How bad any side effects are.
Objectives:
Primary:
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Secondary:
- To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;
- To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules;
- To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules;
- To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules;
- To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules;
- To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;
- To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety;
- To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab;
- To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.
Detailed description
The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Nimotuzumab Humanized Monoclonal Antibody, Drug: NimotuzumabNimotuzumab 400mg every week or every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies.
- Measurable disease,
- Must have clinical documentation of failure after receiving at least one chemotherapy regimen for metastatic disease that contained irinotecan.
- Must have documentation of failure by CT, MRI or PET scan. Patients who were intolerant of irinotecan despite dose attenuations are not eligible for this trial.
- Patients must have failed irinotecan which they received on one of the following three starting regimens:Weekly,Biweekly or every 3 weeks. mg/m2.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nimotuzumab Humanized Monoclonal AntibodyNimotuzumab 400mg every week | Drug | 2 |
| NimotuzumabNimotuzumab 400mg every 2 weeks | Drug | 2 |
Primary outcome
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Time frame: 18-24 months
1 secondary outcome
Assess the incidence of acneiform rash,drug reaction,adverse events, the assessment of progression-free survival,stable disease,time to disease progression, overall survival, objective response rates, safety and trough levels in the serum of patients.
Time frame: 18-24 months
Results and safety
The study was stopped early (reason given: Cohort 2 not going forward. Manadate changes in Company). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2008.
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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.
Amil Shah, MD study chair
Vancouver Cancer Centre BC cancer Agency
12 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 Nimotuzumab Humanized Monoclonal Antibody and Nimotuzumab in people with Colorectal Cancer, run by YM BioSciences at 12 sites in Canada.
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 23 inclusion and 0 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 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. 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 was stopped early (reason given: Cohort 2 not going forward. Manadate changes in Company). 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?
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer (time frame: 18-24 months). 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 17 Nov 2008.