1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345696
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : August 24, 2011
Hoffmann-La Roche
Information provided by (Responsible Party):
Unidad Integral de Investigación en Oncología S.L.

Brief Summary:
The purpose of this study is to determinate progression free survival after 9 months of treatment.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Bevacizumab Drug: Capecitabine Drug: Oxaliplatine Phase 2

Detailed Description:

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 Bevacizumab.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.
Study Start Date : June 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Bevacizumab
    5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
    Other Name: Avastin
  • Drug: Capecitabine
    600 mg/m2, orally, every 12 hours, continuous.
    Other Name: Xeloda
  • Drug: Oxaliplatine
    85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
    Other Name: Eloxatin

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Overall Response rate [ Time Frame: 24 months ]
  2. Overall survival [ Time Frame: 24 months ]
  3. Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab [ Time Frame: 24 months ]
  4. Resection rate of hepatic or pulmonary metastases [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 cervix.
  • 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 intake.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345696

Hospital 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Unidad Integral de Investigación en Oncología S.L.
Hoffmann-La Roche
Study Chair: Cristina Grávalos, MD Unidad Integral de Investigación en Oncología S.L.
Principal Investigator: Cristina Grávalos, MD Hospital 12 de Octubre

Responsible Party: Unidad Integral de Investigación en Oncología S.L. Identifier: NCT00345696     History of Changes
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Unidad Integral de Investigación en Oncología S.L.:
First line

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action