A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01490866
Protocol IDs
SCRI GI 154 (primary)
Study Sponsor
Sarah Cannon Research Institute

Summary

This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

Objectives

All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

Treatment Sites in Georgia


Longstreet Cancer Center - Gainesville
725 Jesse Jewel Parkway
3rd Floor
Gainesville, GA 30501
www.longstreetclinic.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Timothy M. Carey MD
Anup K. Lahiry MD
Richard J. LoCicero MD
Charles H. Nash, III MD, FACP

Northeast Georgia Diagnostic Clinic - Gainesville
1240 Jesse Jewell Parkway
Suite 500
Gainesville, GA 30501
www.ngdc.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Padma C. Nadella MD
Saloni H. Tanna MD
Christina A. Saurel MD

Surgical Oncology of Northeast Georgia
690 Medical Park Lane
Gainesville, GA 30501
www.drkendixon.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

P. Kendal Dixon MD

Toccoa Cancer Center
1640 Falls Road
Toccoa, GA 30577
www.nghs.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Geoffrey J. Weidner MD