- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057017
First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras
February 13, 2020 updated by: howard safran, Brown University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Rhode Island Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
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 |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
every 3 weeks until patient comes off study (progressive disease), for up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: howard p safran, MD, Lifespan Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 26, 2010
First Posted (Estimate)
January 27, 2010
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BrUOG-CR-218
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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