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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00851045Tipo: INTERVENTIONALInicio: 1 de oct de 2009Fin estimado: 1 de oct de 2011

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

Ubicaciones

Local Institution

Bahía Blanca, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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