Metastatic Colorectal CancerPhase 1/2IXO+ANCT00819754
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
A Phase 1/2 study testing IXO regimen + bevacizumab in people with Metastatic Colorectal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- IXO regimen + bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2003to May 2012
- Phase
- Phase 1/2
- 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
- Histologically documented adenocarcinoma of the colon or rectum.
- Advanced and/or metastatic disease, incurable with standard therapy.
- Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Age: over 18 years.
- Adequate haematological, renal and hepatic functions
- Patient consent must be obtained according to local REB requirements.
- Patients must be accessible for treatment and follow up.
Who cannot join
- Previous or concurrent malignancies
- Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
- Concurrent treatment with other experimental drugs or anticancer therapy.
- Previous chemotherapy for advanced and/or metastatic disease.
- Previous adjuvant therapy with irinotecan or oxaliplatin.
- Previous full dose curative pelvic radiation therapy.
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- Patients with documented brain metastases.
- Serious illness or medical condition.
- Gilbert's disease
- Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- IXO regimen + bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXO regimen + bevacizumabDrug
Also called irinotecan - Camptosar, capecitabine - Xeloda, Oxaliplatin - Eloxatin, bevacizumab - Avastin
Phase I study - identifies the safety of IXO with bevacizumab and recommended phase II dose
Phase II study - assesses efficacy and safety of IXO with bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| IXO regimen + bevacizumab | Experimental | This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab) Receives: Drug: IXO regimen + bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
Measured: 3-week cycle, continuous monitoring of AE
Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
Measured: 3-week cycle, continuous monitoring of AE
Secondary outcomes (3)
Response rates and duration of response
Measured: every 2 cycles - 6 weeks
Overall survival
Measured: continuous
Qualitative and quantitative toxicity
Measured: continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startNov 2003
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Pfizer, Sanofi, Ottawa Regional Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jean Maroun, MD, Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819754
- Sponsor's protocol ID
- 0TT 03-03
- Acronym
- IXO+A
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2009
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00819754
- Acronym / sponsor ID
- IXO+A / 0TT 03-03
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Pfizer, Sanofi, Ottawa Regional Cancer Foundation
- Study start
- Nov 2003
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 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.
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IXO regimen + bevacizumab | Experimental | Drug: IXO regimen + bevacizumabThis is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically documented adenocarcinoma of the colon or rectum.
- Advanced and/or metastatic disease, incurable with standard therapy.
- Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Age: over 18 years.
Key exclusion criteria (10 listed)
- Previous or concurrent malignancies
- Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
- Concurrent treatment with other experimental drugs or anticancer therapy.
- Previous chemotherapy for advanced and/or metastatic disease.
- Previous adjuvant therapy with irinotecan or oxaliplatin.
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 |
|---|---|---|
| IXO regimen + bevacizumabAlso: irinotecan - Camptosar, capecitabine - Xeloda, Oxaliplatin - Eloxatin, bevacizumab - AvastinPhase I study - identifies the safety of IXO with bevacizumab and recommended phase II dose Phase II study - assesses efficacy and safety of IXO with bevacizumab | Drug | IXO regimen + bevacizumab |
Primary outcome
Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
Time frame: 3-week cycle, continuous monitoring of AE
Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
Time frame: 3-week cycle, continuous monitoring of AE
3 secondary outcomes
Response rates and duration of response
Time frame: every 2 cycles - 6 weeks
Overall survival
Time frame: continuous
Qualitative and quantitative toxicity
Time frame: continuous
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Jean Maroun, MD principal investigator
The Ottawa Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IXO regimen + bevacizumab in people with Metastatic Colorectal Cancer, run by Ottawa Hospital Research Institute at 1 site 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 8 inclusion and 10 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 14 Jan 2014. 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 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 combined 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.
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. 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?
Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC (time frame: 3-week cycle, continuous monitoring of AE). The study lists 2 primary outcomes in all. 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 14 Jan 2014.