Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer

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

Conditions

• 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
• Stage IV Rectal Cancer

Interventions

BIOLOGICAL

aflibercept

4 mg/kg as a 1-hour IV(intervenous) infusion

DRUG

oxaliplatin

85 mg/m2 IV infused over 2 hours

DRUG

leucovorin

200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin

DRUG

fluorouracil

400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.

OTHER

Correlative Studies

Patients are required to have tissue 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.

PROCEDURE

DCE MRI

Images at weeks 0, and after 8 weeks +/- 1 week of treatment (after Cycle 2).

RADIATION

f18FDG-PET

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).

PROCEDURE

PET (positron emission tomography)

Correlative studies

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• John Hays

  lead OTHER

Principal Investigators

• John Hays, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-14

Primary Completion

2019-08-06

Completion

2022-08-30

FDA Drug

Yes

Countries

• United States

Study Locations