5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

February 29, 2012

Conditions
Rectal CancerCancer of the RectumColorectal Cancer
Interventions
DRUG

5-Fluorouracil

"Combined Modality Treatment:~fluorouracil 225mg/m2 IV continuous infusion days 1-42~Systemic Treatment:~5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15"

DRUG

Bevacizumab

"Combined Modality Treatment:~bevacizumab 5mg/kg IV infusion days 1, 15, and 29~Systemic Treatment:~bevacizumab 5 mg/kg days 1 and 15"

PROCEDURE

Radiation Therapy

radiation 1.8 Gy/day or 28 fractions weeks 1-6

DRUG

Oxaliplatin

"Systemic Treatment:~oxaliplatin 85 mg/m2 days 1 and 15"

DRUG

Leucovorin

"Systemic Treatment:~leucovorin 350 mg prior to FU on days 1 and 15"

Trial Locations (14)

19026

Consultants in Medical Oncology and Hematology, Drexel Hill

23601

Peninsula Cancer Institute, Newport News

29303

Spartanburg Regional Medical Center, Spartanburg

30060

Wellstar Cancer Research, Marietta

30501

Northeast Georgia Medical Center, Gainesville

32256

Integrated Community Oncology Network, Jacksonville

33805

Watson Clinic Center for Cancer Care and Research, Lakeland

33901

Florida Cancer Specialists, Fort Myers

36207

Northeast Alabama Regional Medical Center, Anniston

37205

Tennessee Oncology, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

40207

Consultants in Blood Disorders and Cancer, Louisville

72401

Northeast Arkansas Clinic, Jonesboro

78258

South Texas Oncology and Hematology, San Antonio

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER