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Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer

NCT02129257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2017-10-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AFLIBERCEPT

DRUG

Irinotecan

DRUG

5-Fluorouracil

DRUG

Folinic Acid

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hellenic Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • George Pentheroudakis, MD, Ass.Prof · Dept of Medical Oncology, Ioannina University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-26
Primary Completion
2017-01-31
Completion
2017-09-25

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02129257 on ClinicalTrials.gov