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Evaluation Study of Hypertension as a Predictor of Efficacy Bevacizumab (BV) in Combination With Chemotherapy (CT) in Metastatic Colorectal Cancer (MCC) and Metastatic Breast Cancer (MBC).

18 Years
Open (Enrolling)
Metastatic Colorectal Cancer, Metastatic Breast Cancer

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Trial Information

Evaluation Study of Hypertension as a Predictor of Efficacy Bevacizumab (BV) in Combination With Chemotherapy (CT) in Metastatic Colorectal Cancer (MCC) and Metastatic Breast Cancer (MBC).

Hypertension (HT) is the most common side effect seen in trials of bevacizumab in
combination with chemotherapy. Based on the hypothesis that the development of hypertension
during treatment would be an indicative of the successful blockade of the VEGF pathway,
different studies have explored retrospectively the relationship between hypertension and
the results of treatment with bevacizumab.

This study aims to demonstrate the association between hypertension (diagnosed optimally)
with efficacy to treatment with bevacizumab prospectively and secondly verify if blood
pressure measures taken at home are a reflection of a diagnosis of hypertension.

Also have been explored different molecular markers involved in the pathway of VEGF which
might be used as predictors of response. Therefore, this study includes the collection of
blood samples (serum or plasma) and tumor tissue of patients included in this study, with
the aim of exploring biomarkers that correlate with treatment efficacy and toxicity.

The diagnosis of hypertension (HT) will be performed using a Holter recording, and standard
blood pressure footage will be collected during the first three cycles of treatment given
the Common Toxicity Criteria of the National Cancer Institute-NCI CTCAE version 4.0 and the
guidelines of the European Society of Cardiology and Hypertension, 2007.

Will be collected a sample of primary tumor and blood for patients who previously have
consented it. Samples will be sent to a central laboratory for analysis of biomarkers.

An interim analysis will be conducted to assess the true incidence of hypertension. Based on
this analysis, will be evaluated the need to recalculate the sample size.

At the end of the study, will be performed an analysis of correlation of data measured by
HTA and Holter recording footage with the SLP standard TA. Moreover will be determined in
serum, plasma and tumor tissue and certain biomarkers to correlate with efficacy to
treatment with bevacizumab.

Inclusion Criteria:

May only participate in the study patients (women and men) who meet all the following

1. MCC or MBC patients with chemotherapy and bevacizumab established indication. The
first line systemic treatment planned for patients with MCC should be based in
combination chemotherapy (oxaliplatin / irinotecan plus fluoropyrimidine) associated
with bevacizumab. The first line systemic treatment planned for MBC patients should
be based on a combination of paclitaxel or capecitabine plus bevacizumab.

2. Presence of measurable or evaluable disease according to RECIST 1.1, for the
evaluation of the response to treatment.

3. Equal or more than 18 years old.

4. ECOG performance status of 0 or 1.

5. Signed written informed consent.

6. Women of childbearing potential must have a negative pregnancy test in serum or urine
conducted in the 7 days prior to the administration of chemotherapeutic treatment
assigned by your doctor, and accept the use of double barrier contraception during
the study (Note : Patients who are not of childbearing age may participate without
using contraceptives. Women who are of childbearing age are those who: 1) have
reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum
FSH within postmenopausal interval as determined by the laboratory, or 12 months of
spontaneous amenorrhea), 2) have undergone bilateral oophorectomy with or without
hysterectomy 6 weeks before, or 3) have undergone bilateral tubal ligation). Men also
should use an adequate contraception method.

Exclusion Criteria:

Patients meeting any of the following circumstances will be excluded from the study:

1. Have received prior systemic anticancer therapy with chemotherapy for advanced
disease or prior treatment with bevacizumab.

2. Treatment with an investigational agent or biological agent within 30 days prior to
inclusion in the study.

3. Contraindications to treatment with chemotherapy and bevacizumab according to summary
products characteristics.

4. Background or current history (within five years before the start of treatment) of
other malignancies, except for colorectal carcinoma and breast cancer (patients with
basal cell carcinoma or squamous cell skin or cervical carcinoma in situ treated
curative may be included in the study).

5. Life expectancy less than 3 months.

6. Patients who are pregnant or breastfeeding.

7. Patients with an inadequate organ function (bone marrow, kidney and liver)

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Blood Pressure

Outcome Description:

Blood Pressure will be determined at a baseline, within 14 days before the start of treatment, and on the first day of cycles 1, 2 and 3. Measurement tools for recording blood pressure: Holter o Ambulatory Blood Pressure Monitoring Standard Register Blood Pressure following the guidelines of the European Society of Cardiology and Hypertension, 2007

Outcome Time Frame:

3 months after the first blood pressure assessment

Safety Issue:


Principal Investigator

Alvaro Rodríguez Lescure

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital General Universitario de Elche


Spain: Ethic Committee

Study ID:




Start Date:

November 2012

Completion Date:

December 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic Breast Cancer
  • Hypertension
  • Bevacizumab Response Predictors
  • Metastatic Breast Cancer
  • Metastatic Colon Cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Hypertension