Angiogenic Switch in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

— ANGIOSWITCH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02075086
• Other study ID #: ANGIOSWITCH2011
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 17, 2011
• Last updated: March 13, 2015
• Start date: July 2011
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Grupo Hospital de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Xelox or Xeliri Bevacizumab
Chemotherapy treatment

Locations

Country	Name	City	State
Spain	Centro Integral oncológico Clara Campal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Hospital de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Days from cycle one day one to progression	1 year	No
Secondary	Feasibility	Feasibility of doing a clinical prospective trial with a measure od plasma citoquines.	2 years	No