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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Unidad Integral de Investigación en Oncología S.L.
ClinicalTrials.gov Identifier:
NCT00345696
First received: June 27, 2006
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Bevacizumab
Drug: Capecitabine
Drug: Oxaliplatine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Unidad Integral de Investigación en Oncología S.L.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Resection rate of hepatic or pulmonary metastases [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2006
Study Completion Date: January 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345696

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

No publications provided

Responsible Party: Unidad Integral de Investigación en Oncología S.L.
ClinicalTrials.gov Identifier: NCT00345696     History of Changes
Other Study ID Numbers: XELOXAVBISEMANAL
Study First Received: June 27, 2006
Last Updated: August 23, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014