Colorectal Cancer (CRC)
Conditions
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
Interventions
DRUGIrinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
DRUG5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
DRUG5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
DRUGLeucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
DRUGCT-322
Solution, IV, 2 mg/kg, Q7 days, Until PD
DRUGBevacizumab
Solutions, IV, 5 mg/kg, Q14 days, Until PD
DRUGBevacizumab Placebo (saline solution)
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time the subject is randomized until death, in each arm | every 12 weeks |
| 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 |
| 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 |
Countries
Argentina, Italy, United States
Outcome results
None listed