Colorectal CancerPhase 2NCT00483834
A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer
A Phase 2 study testing Bevacizumab, Irinotecan and Capecitabine in people with Colorectal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Bevacizumab has recently been shown to improve survival when combined with chemotherapy in patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given together with infusional 5-FU, which requires a central line. 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?
- Bevacizumab, Irinotecan and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Jul 2011
- 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
- Patients must have histologically or cytologically confirmed colorectal cancer which is recurrent or metastatic, and not amendable to surgical resection or radiation.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 11.2 for the evaluation of measurable disease.
- Patients must have had no previous chemotherapy or treatment with an investigational agent for recurrent or metastatic disease. Prior chemotherapy in the adjuvant setting for colorectal cancer is acceptable. Prior surgery or radiotherapy for recurrent or metastatic disease is acceptable, however, patients must be adequately recovered from the effects of these treatments. At least 6 weeks must have elapsed from major surgery and 4 weeks must have elapsed from any radiation therapy.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab in combination with capecitabine and irinotecan in patients <18 years of age, children are excluded from this study.
- Estimated life expectancy of greater than 3 months.
- ECOG performance status 0, 1, or 2 (or Karnofsky >60%; see Appendix A).
Show all 11Show fewer
- Patients must have normal organ and marrow function as defined below:
- leukocytes >/= 3,000/mcL absolute neutrophil count >/= 1,500/mcL platelets >/= 100,000/mcL hemoglobin >/= 90 g/L total bilirubin </= 1.5 x upper limit of normal AST(SGOT)/ALT(SGPT) </= 2.5 x upper limit of normal creatinine within normal institutional limits OR creatinine clearance >/= 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal proteinuria < 2+ on dipstick patients with >/= 2+ proteinuria on urine dipstick at baseline should undergo a 24-hour urine collection, and must have </= 1g protein / 24 hours
- Appropriate imaging investigations, including chest X-rays and / or CT/MRI of chest / abdomen / pelvis or other scans as clinically indicated to document all sites of disease must be performed within 28 days of study entry.
- The effects of bevacizumab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study and for a period of four weeks after cessation of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid malignancies curatively treated with no evidence of disease for ≥ 5 years.
- Patients may not be receiving any other investigational agents.
- Patients with known metastases in the central nervous system.
- Any condition that does not permit compliance with the study protocol
- Previous history of gastrointestinal perforation, uncontrolled gastrointestinal bleeding, uncontrolled thromboembolism
- Presence of uncontrolled hypertension and / or proteinuria. Patients must have systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 100 mmHg, and be on stable blood pressure medication at the time of study entry. Patients discovered to have ≥ 1+ proteinuria at baseline, should undergo a 24-hour urine collection and must have < 500 mg of protein / 24 hours.
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- History of allergic reactions, or intolerance, attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, or bevacizumab.
- Women who are pregnant or breastfeeding are excluded from this study because bevacizumab is an antiangiogenic agent 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 bevacizumab, breastfeeding should be discontinued if the mother is treated with bevacizumab. These potential risks may also apply to other agents used in this study.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the agents used in this study. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Patients with active cardiovascular disease, i.e., 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 attach (TIA)) within 6 months prior to study entry will be excluded.
- Patients who had major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first study treatment, or anticipation of need for major surgical procedure during the course of the study; minor surgical procedures within 7 days prior to study treatment start.
- Planned radiotherapy for underlying disease.
- Serious non-healing wound or ulcer.
- Evidence of bleeding diathesis or coagulopathy.
- Current or recent (within 10 days prior to study treatment start) use of full dose oral or intravenous anticoagulants or thrombolytic agents. Patients on low molecular weight heparins are allowed to participate in the study. Patients with anticoagulation for maintenance of patency of permanent indwelling intravenous catheters will be eligible. However, INR should be monitored closely if patients are taking low-dose coumadin for this purpose.
- Ongoing treatment with aspirin ( > 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
- Patients who have received prior radiation therapy to > 15% of bone marrow (see Appendix D), or standard pelvic radiation for rectal cancer.
- Patients with predisposing colonic or small bowel disorders in which symptoms are uncontrolled as indicated by pre-treatment/baseline pattern of > 3 loose stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may be entered as the investigator's discretion.
- Patients with partial or complete bowel obstruction, known chronic malabsorption, total colectomy or other major abdominal surgery that might result in substantial alteration in absorption of oral medications.
- Patients with known Gilbert's syndrome.
- Patients who were started on phenytoid, phenobarbital, carbamazepine or any other enzyme-inducing anti-convulsant drug (EIACD) within 7 days prior to the first study treatment or patients who are unable or unwilling to discontinue EIACD use or switch to a non-EIACD at least 7 days prior to the first study treatment. Concomitant use of gabapentin or other non-EIACDs is permitted.
- Patients who are unable or unwilling to discontinue St. John's wort (hypericum perforatum) at least 14 days prior to the first study treatment; Patients who are taking fluconazole / ketoconazole at the time of first study treatment.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Organ allografts requiring immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Bevacizumab has recently been shown to improve survival when combined with chemotherapy in patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given together with infusional 5-FU, which requires a central line. A central line is inconvenient for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line increases resource demands for interventional radiology, chemo daycare. Capecitabine is administered orally, and converted to 5-FU intracellularly. Chronic administration of capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy for patients with metastatic colorectal cancer.
Read the detailed description
The FOLFIRI regimen has become the standard 1st line therapy for metastatic colorectal cancer in Canada. This regimen consists of irinotecan in combination with bolus 5-FU/leucovorin, followed by 46-hour infusional 5-FU every 2 weeks. It requires a central line and an infusion pump for delivering 5-FU, and necessitates at least 2 visits to the chemotherapy units every 2 weeks, which not only incurs additional cost and inconvenience to patients, but also increases the risk of complications such as thrombosis and infection due to the central line. In addition, due to resources limitations, patients often have to wait several weeks for central line placement. The XELIRI (irinotecan and capecitabine) regimen has been in use at the Princess Margaret Hospital (PMH) as the first-line treatment of patients with metastatic colorectal cancer since May, 2003. The choice of XELIRI over FOLFIRI was made in efforts to reduce demands on resources, enable patients to start therapy sooner, increase patient convenience and potentially reduce complications associated with central venous access. The regimen consists of irinotecan 250 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 PO BID from days 1-14 every 3 weeks. The dose was reduced to irinotecan 200 mg/m2 on day 1 and capecitabine 750 mg/m2 in patients > 65 years old or in patients with renal impairment. So far, 101 patients have been treated on this regimen at PMH. Among 76 patients evaluable for response, there have been 34 confirmed partial responses (44.7%) and a further 18 patients with stable disease (23.7%), for a disease control rate of 68.4%. Furthermore, this regimen was well tolerated with main side effects being diarrhea and neutropenia. With availability of bevacizumab, 12 patients were treated with the XELIRI regimen in combination with bevacizumab at PMH as part of the BEAT (Bevcizumab Expanded Access Trial ) study up to October, 2005. Of 10 patients who were treated with 3 or more cycles of chemotherapy, there were 7 confirmed partial responses and 2 additional patients with stable disease. One patient with non-measurable but evaluable disease had marked reduction in infiltration in the sacrum. There were no instances of GI perforation, febrile neutropenia, or toxic death. The median number of cycles of treatment was 6, and 9 of 12 patients are still receiving treatment. There were, however, a total of 8 dose reductions of capecitabine in 6 patients, with majority of dose reductions as a result of hand-foot syndrome. Although these efficacy and toxicity data are extremely encouraging, the small number of patients limits the potential application of these data.Because of the encouraging preliminary results, it is necessary to conduct a prospective clinical study to further evaluate the efficacy and toxicity of irinotecan, capecitabine and bevacizumab combination (the XELIRI-A regimen) as first-line chemotherapy for patients with advanced colorectal cancer. Results from this study would provide the scientific basis for a randomized phase III study to compare the XELIRI-A regimen to the IFL (FOLFIRI) + bevacizumab regimen. Furthermore, it will have practical implications for our centre. Compared to infusional or bolus 5-FU based regimens, the XELIRI-A regimen will reduce workload in the chemotherapy daycare unit and drug costs, reduce demands for resources such as infusion pumps and interventional radiology time, enable patients to start therapy sooner, and improve patient convenience.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab, Irinotecan, Capecitabine
- Keywords
- Bevacizumab, Avastin, CPT-11, Irinotecan, Camptothecin-11, Capecitabine, Xeloda, Metastatic, Colorectal, Colon, Rectal
- 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.
BevacizumabDrug
Also called Avastin, VEGF, rhuMAb
7.5mg/kg, IV, day 1 of each cycle
IrinotecanDrug
Also called CPT-11, hydrochloride trihydrate, Camptosar
200mg/m^2, IV, day 1 each cycle
CapecitabineDrug
Also called Xeloda
1000mg/m^2 or 750mg/m^2 for patients over 65yrs old PO BID, day 1-14 each cycle
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab, Irinotecan and Capecitabine | Experimental | Evaluate the efficacy and toxicity of bevacizumab, irinotecan and capecitabine as first-line treatment for patients with metastatic colorectal cancer Receives: Drug: Bevacizumab; Drug: Irinotecan; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To determine the objective response rate (ie. the rate of partial response plus complete response as defined by RECIST criteria) of irinotecan, capecitabine and bevacizumab (XELIRI-A) in patients with previously untreated metastatic colorectal cancer.
Measured: Radiological evaluation every 9 weeks, with confirmatory scans 4 weeks after objective response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startDec 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Eric Chen, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483834
- Sponsor's protocol ID
- XELIRI-A
- Status last verified
- Feb 2019
- First submitted
- 6 Jun 2007
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Renouf DJ, Welch S, Moore MJ, Krzyzanowska MK, Knox J, Feld R, Liu G, MacKay H, Petronis J, Wang L, Chen E. A phase II study of capecitabine, irinotecan, and bevacizumab in patients with previously untreated metastatic colorectal cancer. Cancer Chemother Pharmacol. 2012 May;69(5):1339-44. doi: 10.1007/s00280-012-1843-9. Epub 2012 Feb 15.
PubMed 22349811
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00483834
- Acronym / sponsor ID
- XELIRI-A
- Conditions
- Colorectal Cancer
- Keywords
- Bevacizumab, Avastin, CPT-11, Irinotecan, Camptothecin-11, Capecitabine, Xeloda, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 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.
Bevacizumab has recently been shown to improve survival when combined with chemotherapy in patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given together with infusional 5-FU, which requires a central line. A central line is inconvenient for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line increases resource demands for interventional radiology, chemo daycare. Capecitabine is administered orally, and converted to 5-FU intracellularly. Chronic administration of capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy for patients with metastatic colorectal cancer.
Detailed description
The FOLFIRI regimen has become the standard 1st line therapy for metastatic colorectal cancer in Canada. This regimen consists of irinotecan in combination with bolus 5-FU/leucovorin, followed by 46-hour infusional 5-FU every 2 weeks. It requires a central line and an infusion pump for delivering 5-FU, and necessitates at least 2 visits to the chemotherapy units every 2 weeks, which not only incurs additional cost and inconvenience to patients, but also increases the risk of complications such as thrombosis and infection due to the central line. In addition, due to resources limitations, patients often have to wait several weeks for central line placement. The XELIRI (irinotecan and capecitabine) regimen has been in use at the Princess Margaret Hospital (PMH) as the first-line treatment of patients with metastatic colorectal cancer since May, 2003. The choice of XELIRI over FOLFIRI was made in efforts to reduce demands on resources, enable patients to start therapy sooner, increase patient convenience and potentially reduce complications associated with central venous access. The regimen consists of irinotecan 250 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 PO BID from days 1-14 every 3 weeks. The dose was reduced to irinotecan 200 mg/m2 on day 1 and capecitabine 750 mg/m2 in patients > 65 years old or in patients with renal impairment. So far, 101 patients have been treated on this regimen at PMH. Among 76 patients evaluable for response, there have been 34 confirmed partial responses (44.7%) and a further 18 patients with stable disease (23.7%), for a disease control rate of 68.4%. Furthermore, this regimen was well tolerated with main side effects being diarrhea and neutropenia. With availability of bevacizumab, 12 patients were treated with the XELIRI regimen in combination with bevacizumab at PMH as part of the BEAT (Bevcizumab Expanded Access Trial ) study up to October, 2005. Of 10 patients who were treated with 3 or more cycles of chemotherapy, there were 7 confirmed partial responses and 2 additional patients with stable disease. One patient with non-measurable but evaluable disease had marked reduction in infiltration in the sacrum. There were no instances of GI perforation, febrile neutropenia, or toxic death. The median number of cycles of treatment was 6, and 9 of 12 patients are still receiving treatment. There were, however, a total of 8 dose reductions of capecitabine in 6 patients, with majority of dose reductions as a result of hand-foot syndrome. Although these efficacy and toxicity data are extremely encouraging, the small number of patients limits the potential application of these data.Because of the encouraging preliminary results, it is necessary to conduct a prospective clinical study to further evaluate the efficacy and toxicity of irinotecan, capecitabine and bevacizumab combination (the XELIRI-A regimen) as first-line chemotherapy for patients with advanced colorectal cancer. Results from this study would provide the scientific basis for a randomized phase III study to compare the XELIRI-A regimen to the IFL (FOLFIRI) + bevacizumab regimen. Furthermore, it will have practical implications for our centre. Compared to infusional or bolus 5-FU based regimens, the XELIRI-A regimen will reduce workload in the chemotherapy daycare unit and drug costs, reduce demands for resources such as infusion pumps and interventional radiology time, enable patients to start therapy sooner, and improve patient convenience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab, Irinotecan and Capecitabine | Experimental | Drug: Bevacizumab, Drug: Irinotecan, Drug: CapecitabineEvaluate the efficacy and toxicity of bevacizumab, irinotecan and capecitabine as first-line treatment for patients with metastatic colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically or cytologically confirmed colorectal cancer which is recurrent or metastatic, and not amendable to surgical resection or radiation.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 11.2 for the evaluation of measurable disease.
- Patients must have had no previous chemotherapy or treatment with an investigational agent for recurrent or metastatic disease. Prior chemotherapy in the adjuvant setting for colorectal cancer is acceptable. Prior surgery or radiotherapy for recurrent or metastatic disease is acceptable, however, patients must be adequately recovered from the effects of these treatments. At least 6 weeks must have elapsed from major surgery and 4 weeks must have elapsed from any radiation therapy.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab in combination with capecitabine and irinotecan in patients <18 years of age, children are excluded from this study.
- Estimated life expectancy of greater than 3 months.
Key exclusion criteria (25 listed)
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid malignancies curatively treated with no evidence of disease for ≥ 5 years.
- Patients may not be receiving any other investigational agents.
- Patients with known metastases in the central nervous system.
- Any condition that does not permit compliance with the study protocol
- Previous history of gastrointestinal perforation, uncontrolled gastrointestinal bleeding, uncontrolled thromboembolism
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 |
|---|---|---|
| BevacizumabAlso: Avastin, VEGF, rhuMAb7.5mg/kg, IV, day 1 of each cycle | Drug | Bevacizumab, Irinotecan and Capecitabine |
| IrinotecanAlso: CPT-11, hydrochloride trihydrate, Camptosar200mg/m^2, IV, day 1 each cycle | Drug | Bevacizumab, Irinotecan and Capecitabine |
| CapecitabineAlso: Xeloda1000mg/m^2 or 750mg/m^2 for patients over 65yrs old PO BID, day 1-14 each cycle | Drug | Bevacizumab, Irinotecan and Capecitabine |
Primary outcome
Objective Response Rate
Time frame: Radiological evaluation every 9 weeks, with confirmatory scans 4 weeks after objective response
To determine the objective response rate (ie. the rate of partial response plus complete response as defined by RECIST criteria) of irinotecan, capecitabine and bevacizumab (XELIRI-A) in patients with previously untreated metastatic colorectal cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Results publication: PubMed 22349811Renouf DJ, Welch S, Moore MJ, Krzyzanowska MK, Knox J, Feld R, Liu G, MacKay H, Petronis J, Wang L, Chen E. A phase II study of capecitabine, irinotecan, and bevacizumab in patients with previously untreated metastatic colorectal cancer. Cancer Chemother Pharmacol. 2012 May;69(5):1339-44. doi: 10.1007/s00280-012-1843-9. Epub 2012 Feb 15.
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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.
Eric Chen principal investigator
Princess Margaret Hospital, Canada
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 Bevacizumab, Irinotecan and Capecitabine in people with Colorectal Cancer, run by University Health Network, Toronto 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 11 inclusion and 25 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 15 Feb 2019. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (time frame: Radiological evaluation every 9 weeks, with confirmatory scans 4 weeks after objective response). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483834, which also lists 1 linked publication.
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 15 Feb 2019.