Angiogenic Switch in Patients With Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Xelox or Xeliri Bevacizumab

• Registration Number: NCT02075086
• Lead Sponsor: Grupo Hospital de Madrid

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-03-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy treatment	Xelox or Xeliri Bevacizumab	Chemotherapy treatment with Xelox or Xeliri and bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year	Days from cycle one day one to progression

Secondary Outcome Measures

Name	Time	Method
Feasibility	2 years	Feasibility of doing a clinical prospective trial with a measure od plasma citoquines.

Trial Locations

Locations (1)

Centro Integral oncológico Clara Campal; 🇪🇸 Madrid, Spain