Angiogenic Switch in Patients With Colorectal Cancer (ANGIOSWITCH)

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

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 .

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Xelox or Xeliri Bevacizumab

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chemotherapy treatment; Chemotherapy treatment with Xelox or Xeliri and bevacizumab	Drug: Xelox or Xeliri Bevacizumab; Chemotherapy treatment; Other Names: Cytokines measure; Angiogenic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Days from cycle one day one to progression	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Feasibility of doing a clinical prospective trial with a measure od plasma citoquines.	2 years

Collaborators and Investigators

• Sponsor: Grupo Hospital de Madrid
• Investigators: Principal Investigator: Antonio Cubillo, MD PhaD, Grupo Hospital de Madrid

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2015
• Study Completion (ANTICIPATED): May 1, 2015

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Colon cancer; angiogenic switch; plasma cytokines
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ANGIOSWITCH2011