A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00399035Tipo: INTERVENTIONALInicio: 1 de nov de 2006Fin estimado: 1 de ago de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Written Informed Consent
Carcinoma of the colon or rectum
One or more measurable lesions

Criterios de exclusión

Specific cardiovascular problems
Specific laboratory ranges
Adjuvant/neoadjuvant therapy within 6-12 months of study entry
Untreated unstable brain or meningeal metastases
Participation in other trials within 30 days

Intervenciones

drug

Cediranib

oral tablet

drug

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

intravenous infusion

drug

XELOX (Capecitabine and Oxaliplatin)

intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)

drug

Cediranib Placebo

oral tablet

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Capital Federal, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Resistencia, Argentina

Research Site

Rosario, Argentina

Research Site

Santa Fe, Argentina

Patrocinadores

PrincipalAstraZeneca

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomised, Double-blind, Phase III Study to Compare th... | EligiMed