Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

September 30, 2011

Study Completion Date

October 31, 2011

Conditions
Colorectal Cancer (CRC)
Interventions
DRUG

Irinotecan

Solution, IV, 180 mg/m2, Q14 days, Until PD

DRUG

5-Fluorouracil (bolus)

Solution, IV, 400 mg/m2, Q14 days, Until PD

DRUG

5-Fluorouracil (infusional)

Solution, IV, 2400 mg/m2, Q14 days, Until PD

DRUG

Leucovorin calcium

Solution, IV, 400 mg/m2, Q14 days, Until PD

DRUG

CT-322

Solution, IV, 2 mg/kg, Q7 days, Until PD

DRUG

Bevacizumab

Solutions, IV, 5 mg/kg, Q14 days, Until PD

DRUG

Bevacizumab Placebo (saline solution)

Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD

Trial Locations (15)

1426

Local Institution, Capital Federal

8000

Local Institution, Bahía Blanca

18840

Guthrie Clinic, Ltd, Sayre

33916

Florida Cancer Specialists, Fort Myers

37203

Sarah Cannon Research Institute, Nashville

60432

Midwest Center For Hematology/Oncology, Joliet

67214

Cancer Center Of Kansas, Wichita

70006

Gurtler, Jayne, Metairie

77030

University Of Texas M.D. Anderson Cancer Center, Houston

85715

Acrc/Arizona Clinical Research Center, Inc., Tucson

92123

Sharp Memorial Hospital, San Diego

92501

Compassionate Cancer Care Medical Group, Inc, Riverside

92708

Compassionate Cancer Care Medical Group Inc, Fountain Valley

02915

Pharma Resource, East Providence

05100

Local Institution, Terni

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY