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

NCT00345696 | Completed Phase 2

• 1 other identifier: XELOXAVBISEMANAL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Keywords

Capecitabine; Oxaliplatin; Bevacizumab; First line

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  9 months

Secondary Outcomes (4)

• Overall Response rate

  24 months

• Overall survival

  24 months

• Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab

  24 months

• Resection rate of hepatic or pulmonary metastases

  24 months

Interventions

Bevacizumab DRUG

5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.

Also known as: Avastin

Capecitabine DRUG

600 mg/m2, orally, every 12 hours, continuous.

Also known as: Xeloda

Oxaliplatine DRUG

85 mg/m2, intravenous, 2 hours infusion, every 2 weeks

Also known as: Eloxatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidad Integral de Investigación en Oncología S.L.: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Cristina Grávalos, MD

  Unidad Integral de Investigación en Oncología S.L.

  STUDY CHAIR

• Cristina Grávalos, MD

  Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2011
• Last Updated: August 24, 2011

Record last verified: 2011-08

Locations

ES (1)