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

Colorectal Cancer (CRC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851045
• Other study ID #: CA196-004
• Secondary ID: EUDRACT # 2008-0
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2009
• Last updated: September 23, 2015
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Istituto Superiore de Sanita (ISS)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer (CRC)
• Colorectal Neoplasms

Intervention

Drug:
• Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
• 5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
• 5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
• Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
• CT-322
Solution, IV, 2 mg/kg, Q7 days, Until PD
• Bevacizumab
Solutions, IV, 5 mg/kg, Q14 days, Until PD
• Bevacizumab Placebo (saline solution)
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD

Locations

Country	Name	City	State
Argentina	Local Institution	Bahia Blanca	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Italy	Local Institution	Terni
United States	Pharma Resource	East Providence	Rhode Island
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Compassionate Cancer Care Medical Group Inc	Fountain Valley	California
United States	University Of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Midwest Center For Hematology/Oncology	Joliet	Illinois
United States	Gurtler, Jayne	Metairie	Louisiana
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Compassionate Cancer Care Medical Group, Inc	Riverside	California
United States	Sharp Memorial Hospital	San Diego	California
United States	Guthrie Clinic, Ltd	Sayre	Pennsylvania
United States	Acrc/Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Cancer Center Of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival based on tumor assessments (CT/MRI)		Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent	No
Secondary	Overall survival (OS), defined as the time the subject is randomized until death, in each arm		every 12 weeks	No
Secondary	Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator		every 6 weeks	No
Secondary	Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects		weekly	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form