Clinical trial NCT00851045: Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer (CRC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival based on tumor assessments (CT/MRI)
timeFrame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Secondary outcomes:
measure: Overall survival (OS), defined as the time the subject is randomized until death, in each arm
timeFrame: every 12 weeks
measure: 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
timeFrame: every 6 weeks
measure: 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
timeFrame: weekly
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research Center, Inc.
state: Arizona
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group, Inc
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Joliet
country: United States
facility: Midwest Center For Hematology/Oncology
state: Illinois
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Metairie
country: United States
facility: Gurtler, Jayne
state: Louisiana
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd
state: Pennsylvania
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: University Of Texas M.D. Anderson Cancer Center
state: Texas
city: Bahia Blanca
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Terni
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: