Angiogenic Switch as Predictor of Response to Chemotherapy in Patients With Metastatic Colorectal Cancer

Grupo Hospital de Madrid1 site in 1 country100 target enrollmentJuly 2011

ConditionsColorectal Cancer

InterventionsXelox or Xeliri Bevacizumab

DrugsXelox or Xeliri Bevacizumab

Overview

Phase: Phase 2
Intervention: Xelox or Xeliri Bevacizumab
Conditions: Colorectal Cancer
Sponsor: Grupo Hospital de Madrid
Enrollment: 100
Locations: 1
Primary Endpoint: Progression Free Survival
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

May 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grupo Hospital de Madrid

Responsible Party

Principal Investigator

Sofia Perea, Director Clinical Trials Unit.

MD, PhD

Grupo Hospital de Madrid

Eligibility Criteria

Inclusion Criteria

•Diagnosis of stage IV colorectal adenocarcinoma.
•Age ≥ 18 years .
•Measurable disease by RECIST criteria.
•Life expectancy ≥ 6 months.
•Candidate to receive treatment with first-line chemotherapy.
•Availability of tumor tissue.

Exclusion Criteria

•Patients who have received prior treatment with first-line chemotherapy for metastatic disease.
•Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev.
•Patients receiving anticoagulant oral treatment.
•Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually
•Patients with bone disease as the only manifestation of the disease.