Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer
Status:
Completed
Trial end date:
2017-09-25
Target enrollment:
Participant gender:
Summary
The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in
metastatic colorectal cancer patients) trial is an investigator-initiated, single arm,
open-label, phase II study. Patients with histologically proven metastatic colorectal
carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both
Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients
wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination
of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with
aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's
refusal of further treatment or death, whichever comes first.