Angiogenic Switch in Patients With Colorectal Cancer

NCT ID: NCT02075086

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-05-31

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 .

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy treatment

Chemotherapy treatment with Xelox or Xeliri and bevacizumab

Group Type: EXPERIMENTAL

Xelox or Xeliri Bevacizumab

Intervention Type: DRUG

Chemotherapy treatment

Interventions

Xelox or Xeliri Bevacizumab

Chemotherapy treatment

Intervention Type: DRUG

Other Intervention Names

Cytokines measure; Angiogenic study

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Hospital de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Sofia Perea, Director Clinical Trials Unit.

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Cubillo, MD PhaD

Role: PRINCIPAL_INVESTIGATOR

Grupo Hospital de Madrid

Locations

Centro Integral oncológico Clara Campal

Madrid, , Spain

Countries

Spain

Other Identifiers

ANGIOSWITCH2011

Identifier Type: -

Identifier Source: org_study_id