Colorectal CancerPhase 2NCT01057017
First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras
A Phase 2 study testing intervention in people with Colorectal Cancer, run by Brown University at 1 site in United States.
Trial summary
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with… 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?
- intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- 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
- Histologically or pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease.
- Patients must not have had disease progression while receiving a minimum of 6 treatments of FOLFOX/bevacizumab. Patients with stable or responding disease on FOLFOX/bevacizumab are eligible. Bevacizumab does not need to be administered with all cycles of FOLFOX.
- At least 3 weeks since prior FOLFOX/bevacizumab.
- Wild type ras
- No potentially curative treatment option.
- ECOG performance status 0-1
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- Age>18, not pregnant or breast-feeding
- Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500/µl; platelet count ≥ 100,000/µl, Creatinine ≤ 2.0 mg/dl, Bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x upper limit of normal (or ≤ 5 x upper limit of normal for patients with liver metastases), Magnesium > lower limit of normal
- Life expectancy of at least 16 weeks
- Must not have uncontrolled severe, intercurrent illness.
- No chemotherapy or radiation therapy within last 3 weeks
- No concurrent anticancer therapy.
- Signed study-specific consent form prior to study entry
Who cannot join
- Prior EGFR inhibitor and prior irinotecan.
- Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of >150/90 mmHg on medication], history of myocardial infarction within 6 months,), New York Heart Association (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia. Patients with an atrial arrhythmia must have this condition well controlled on stable medication. Patients with current or recent (within 6 months) unstable angina are also not eligible.
- Significant bleeding diathesis or coagulopathy
- Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed.
- Serious, nonhealing wound, ulcer, or current healing fracture
- History of cerebral aneurysms or cerebral arteriovenous malformations.
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- Patients with recent (within 12 months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), or clinically significant peripheral artery disease should also be excluded.
- Brain metastases
- Patients with a history of a gastrointestinal fistula or perforation.
- Significant infection or other coexistent medical condition that would preclude protocol therapy.
- Interstitial lung disease
- Patients who have had an organ transplant
- Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active hepatitis B infection
- Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, bladder and cervix are permissible).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02906
About this study
Official title: Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
Read the detailed description
26 patients with advanced colorectal cancer will be given Bevacizumab at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression
- Conditions
- Colorectal Cancer
- Being tested
- intervention
- Keywords
- colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionBiological
Also called Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression., Panitumumab, Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression, Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression Receives: Biological: intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3
Measured: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionDec 2011
Why it stopped: possible lack of efficacy
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 Brown UniversityThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- howard p safran, MD, Principal investigator, lifespan Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057017
- Sponsor's protocol ID
- BrUOG-CR-218
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2010
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
- ClinicalTrials.gov ID
- NCT01057017
- Acronym / sponsor ID
- BrUOG-CR-218
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: possible lack of efficacy
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 4 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
Detailed description
26 patients with advanced colorectal cancer will be given Bevacizumab at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Biological: interventionBevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease.
- Patients must not have had disease progression while receiving a minimum of 6 treatments of FOLFOX/bevacizumab. Patients with stable or responding disease on FOLFOX/bevacizumab are eligible. Bevacizumab does not need to be administered with all cycles of FOLFOX.
- At least 3 weeks since prior FOLFOX/bevacizumab.
- Wild type ras
- No potentially curative treatment option.
Key exclusion criteria (15 listed)
- Prior EGFR inhibitor and prior irinotecan.
- Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of >150/90 mmHg on medication], history of myocardial infarction within 6 months,), New York Heart Association (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia. Patients with an atrial arrhythmia must have this condition well controlled on stable medication. Patients with current or recent (within 6 months) unstable angina are also not eligible.
- Significant bleeding diathesis or coagulopathy
- Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed.
- Serious, nonhealing wound, ulcer, or current healing fracture
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 |
|---|---|---|
| interventionAlso: Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression., Panitumumab, Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression, Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression | Biological | intervention |
Primary outcome
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
Time frame: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
howard p safran, MD principal investigator
lifespan Hospitals
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 intervention in people with Colorectal Cancer, run by Brown University 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 13 inclusion and 15 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 Feb 2020. 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 4 Nov 2013). 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?
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab (time frame: every 3 weeks until patient comes off study (progressive disease), for up to 2 years). 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 Feb 2020.