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Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.

Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.

To look for a new chemotherapy management to get less acute and chronic toxicity and/or an
easier administration treatment line.

This study tries to demonstrate an alternative chemotherapy scheme,continuous
polychemotherapy regimen with less dose with the added effect of the monoclonal antibody

Inclusion Criteria:

- Men and women > or = 18 years

- Outpatients with ECOG performance status ≤ 2.

- Histologically confirmed diagnosis of CRC patients with metastasis.

- Presence of at least one detectable lesion in accordance with RECIST criteria.

- Life expectancy greater than 3 months.

- Patients who are able to understand the study request and want to participate.

- Written informed consent given

Exclusion Criteria:

- Patients who have been treated with Bevacizumab previously.

- Received any systemic treatment previously to treat an advanced or metastatic disease

- Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that
there has been finished at least 6 months before the initial study treatment.

- If the patient has been treated with adjuvant therapy previously, it is not allowed
to be included in the study in case of disease progression during the treatment or
during 6 months later than the end of the treatment.

- If radiotherapy has been administered it has not been administered in the lesion
selected for the study, and the end of the treatment has been finished at least 4
weeks before the study initiation.

- Previous surgical procedure of the IV stage disease is allowed.

- PAst or current history (within the last 5 years) of malignancies except curatively
treated basal and squamous cell carcinoma of the skin, and in-situ carcinoma of the

- History or evidence upon physical examination of central nervous system (CNS) (i.e.
primary cerebral tumour, uncontrolled convulsions with standard medical treatment,
cerebral metastasis or any kind or ictus history).

- History of psychiatric disability judged by the investigator to be clinically
significant precluding informed consent or interfering with compliance for oral drug

- Clinically significant cardiovascular disease (active), i.e, uncontrolled
hypertension, unstable angina, New York Heart Association (NYHA) grade II or greater
congestive heart failure, serious cardiac arrhythmia requiring medication or
peripheral vascular disease. Patients have undergone myocardial infarction in the
previous year of the study initiation will be excluded.

- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome or inability to take oral medications

- Patients subjected to allogenic transplant and request immunotherapy.

- Bone fracture not healed, wounds or severe ulcers.

- Known hemorrhagic diathesis or coagulopathy.

- Uncontrolled and severe intercurrent infections or another severe and uncontrolled
concomitant diseases.

- Moderate or severe renal impairment (creatinine clearance < 30 ml/min (calculated
according to Cockroft-Gault formula) or serum creatinine >1,5 x ULN.

- Any of the following laboratory values:

Absolute neutrophils count (ANC) < 1.5 x 109/l. Platelet count < 100 x 109/l. Hemoglobin <
9 g/dl. INR > 1.5. Total bilirubin > 1.5 ULN. ALT and/or AST > 2.5 x ULN or > 5 x ULN (in
case of hepatic metastasis). Alkaline phosphatase > 2.5 x ULN or >5 x ULN (in case of
hepatic metastasis), or > 10 x ULN (in case of bone metastasis).

- History of unexpected serious adverse events to fluoropyrimidine treatments or known
dihydropyrimidine dehydrogenase (DPD) deficiency.

- Patients subjected to major surgical procedure, open biopsy or who had significant
traumatic injures in 28 days time before the start of the study treatment , or
patients with a major surgery procedure planning during the study period. Fine needle
aspiration biopsy 7 days before the study initiation.

- Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the
start of the study treatment or thrombolytic agents. Low dose of warfarin is allowed,
with an INR ≤ 1.5.

- Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal
anti-inflammatory treatment.

- Participation in another treatment trial within 4 weeks of the study initiation.

- Pregnant (serum positive pregnancy test) or lactating women.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Cristina Grávalos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Unidad Integral de Investigación en Oncología S.L.


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2006

Completion Date:

January 2011

Related Keywords:

  • Metastatic Colorectal Cancer
  • Capecitabine
  • Oxaliplatin
  • Bevacizumab
  • First line
  • Colorectal Neoplasms