Phase 2
N=56
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer
Mucinous Adenocarcinoma of the Colon · Mucinous Adenocarcinoma of the Rectum · Signet Ring Adenocarcinoma of the Colon · Signet Ring Adenocarcinoma of the Rectum · Stage IV Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01652196 ↗Enrolled (actual)
56
Serious AEs
12.5%
Results posted
Feb 2025
Primary outcome: Primary: Proportion of Patients Alive and Progression-free at 15 Months — .482 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aflibercept (Biological); oxaliplatin (Drug); leucovorin (Drug); fluorouracil (Drug); Correlative Studies (Other); DCE MRI (Procedure); f18FDG-PET (Radiation); PET (positron emission tomography) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- John Hays
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Alive and Progression-free at 15 Months |
.482 | — |
| SECONDARY 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 |
0.446 | — |
| SECONDARY Percentage of Patients Able to Undergo Surgery |
5.36 | — |
| SECONDARY Progression Free Survival (PFS) |
7.82 | — |
| SECONDARY Overall Survival |
19.68 | — |
| SECONDARY Incidence of Severe (Grade 3+) Adverse Events or Toxicities, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
33.9; 25; 12.5; 10.7 | — |
| SECONDARY Tolerability in Terms of Number of Patients Who Require Dose Modifications and/or Dose Delays |
50 | — |
| SECONDARY Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial |
2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of colorectal origin that is metastatic or locally advanced and unresectable
- Measurable disease, as defined by RECIST 1.1 criteria: one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with spiral computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm) malignant lymph nodes will be considered measurable if they are >= 15 mm in short axis
- Must not have received any prior systemic therapy for metastatic or locally advanced CRC; prior VEGF inhibitors are not allowed
- Prior adjuvant therapy for CRC including fluoropyrimidines either alone or in combination with oxaliplatin is allowed, provided that all therapy was completed >= 12 months from cancer recurrence, therapy duration was = = 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Hemoglobin >= 9 g/dL (blood transfusion permitted to attain this value)
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin = = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional U
- Urine protein: creatinine ratio (UPCR) = 2 sensory neuropathy at the time of enrollment
- Major surgery within 4 weeks of study start date; the surgical incision should be fully healed prior to initiation of aflibercept
- Female or male patients of reproductive capacity unwilling to use methods appropriate to prevent pregnancy are excluded; effective contraception is required for at least 3 months following the last administration of aflibercept
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (blood pressure [BP] must be well controlled 1 tsp in 24 hours) within the last 5 years; patients with underling conditions that predispose to bleeding, such as bleeding diathesis, known esophageal varices, or tumor involving major vessels, are also excluded
- Inability to understand or comply with study protocol
- Known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies, or any of the treatments in this protocol
Data sourced from ClinicalTrials.gov (NCT01652196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.