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A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer (CRC)

Thank you

Trial Information

A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer


Inclusion Criteria:



- ECOG Performance Status (PS) ≤1

- Histologically or cytologically confirmed, unresectable metastatic colorectal cancer

- Measurable disease by RECIST guidelines

- Evidence of disease progression following first-line therapy with a fluoropyrimidine,
oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)

- Available paraffin embedded tumor tissue

- Willing to give a whole blood sample for the study of proteins and genetic
polymorphisms

Exclusion Criteria:

- Less than 28 days elapsed since major surgery at time of randomization

- Known CNS metastases

- Excessive risk of bleeding (including use of therapeutic anticoagulation other than
low dose aspirin) and history of thrombotic or embolic cerebrovascular accident

- Uncontrolled hypertension

- Clinically significant cardiovascular disease

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or
bleeding skin metastasis

- Known HIV Positive

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival based on tumor assessments (CT/MRI)

Outcome Time Frame:

Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA196-004

NCT ID:

NCT00851045

Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Colorectal Cancer (CRC)
  • Colorectal Neoplasms

Name

Location

Florida Cancer SpecialistsFort Myers, Florida  33901
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Sharp Memorial HospitalSan Diego, California  92123
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
ACRC/Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Compassionate Cancer Care Medical Group, IncFountain Valley, California  92708
Cancer Center of KansasWichita, Kansas  67214
Sarah Cannon Research InstituteNashville, Tennessee  37203
Pharma ResourceEast Providence, Rhode Island  02915
Compassionate Cancer Care Medical Group IncFountain Valley, California  92708
Guthrie Clinic, LtdSayre, Pennsylvania  18840
Gurtler, JayneMetairie, Louisiana  70006