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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Bevacizumab
Capecitabine
Oxaliplatine
Sponsored by
Unidad Integral de Investigación en Oncología S.L.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Capecitabine, Oxaliplatin, Bevacizumab, First line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital 12 de Octubre

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Response rate
Overall survival
Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab
Resection rate of hepatic or pulmonary metastases

Full Information

First Posted
June 27, 2006
Last Updated
August 23, 2011
Sponsor
Unidad Integral de Investigación en Oncología S.L.
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00345696
Brief Title
1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unidad Integral de Investigación en Oncología S.L.
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Capecitabine, Oxaliplatin, Bevacizumab, First line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
600 mg/m2, orally, every 12 hours, continuous.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatine
Other Intervention Name(s)
Eloxatin
Intervention Description
85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Overall Response rate
Time Frame
24 months
Title
Overall survival
Time Frame
24 months
Title
Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab
Time Frame
24 months
Title
Resection rate of hepatic or pulmonary metastases
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Grávalos, MD
Organizational Affiliation
Unidad Integral de Investigación en Oncología S.L.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Grávalos, MD
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

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

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