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Angiogenesis Inhibitor
Aflibercept (combination chemotherapy) for Adenocarcinoma of the Rectum
Phase 2
Waitlist Available
Led By John Hays, MD
Research Sponsored by John Hays
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 15 months from initiation of therapy
Awards & highlights
Study Summary
This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells
Eligible Conditions
- Colorectal Adenocarcinoma
- Adenocarcinoma of the Rectum
- Colon Cancer
- Rectal Cancer
- Adenocarcinoma of the Colon
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 15 months from initiation of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 15 months from initiation of therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients alive and progression-free
Secondary outcome measures
Incidence of severe (grade 3+) adverse events or toxicities, assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Objective response rate (ORR) defined as the proportion of patients who achieve a PR or CR based on RECIST 1.1 criteria divided by the total number of evaluable patients
Overall survival
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Aflibercept (combination chemotherapy)Experimental Treatment8 Interventions
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
PET (positron emission tomography)
2002
Completed Phase 2
~20
Fluorouracil
FDA approved
Leucovorin
FDA approved
Aflibercept
FDA approved
DCE MRI
2007
N/A
~70
Find a Location
Who is running the clinical trial?
John HaysLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,924 Total Patients Enrolled
1 Trials studying Adenocarcinoma of the Rectum
John Hays, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled
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