- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875771
Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients (AVAXIRI)
July 31, 2017 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Phase II Study of Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients
The purpose of this study is to determine efficacy and safety of the biweekly scheme with Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine efficacy and safety of the biweekly scheme with Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.
- Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks
- Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks
- Bevacizumab: 5 mg/kg day 1, every 2 Weeks
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain
- Spanish Cooperative Group for Gastrointestinal Tumour Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years old (men and women)
- ECOG Performance Status ≤ 2.
- Histologically confirmed colorectal adenocarcinoma, metastatic disease.
- No surgery option
- No previous chemotherapy, except adjuvant treatment finished at least 6 months before the study inclusion
- Have at least one measurable lesion according to the RECIST criteria
- At least a 3-month life expectancy.
- Written informed consent given.
Exclusion Criteria:
- Patients who have previously received systemic treatment (for example, cytostatic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
- Patients previously treated with bevacizumab
- Prior adjuvant or neoadjuvant treatment for non-metastatic disease (M0) is allowed, as long as it has concluded at least 6 months before beginning the treatment of the study.
- If adjuvant treatment has previously been administered, the patients cannot have shown progression of the disease during treatment nor during the 6 months following termination thereof.
- Prior radiotherapy is allowed if it has not been administered in the target lesions selected for this study, unless progression of said lesions in the irradiated field is documented, and as long as treatment has concluded at least 4 weeks before beginning the study.
- Prior surgical treatment of the disease in stage IV is allowed.
- Only non evaluable disease (non measurable) as ascitis, pleural effusion, diffuse hepatic, osseous metastasis
- History of another neoplastic disease during the last five years, with the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ.
- History or indications of CNS disease (for example, primary brain tumor, uncontrolled convulsions with standard medical treatment, cerebral metastases of any type or history of ictus) in the physical examination.
- Medication or peripheral vascular disease, grade II or higher. Furthermore, those patients who have had a myocardial infarction in the year prior to beginning the treatment of the study will be excluded.
- History of psychiatric disability that the investigator considers clinically significant, which prevents the patient from granting the informed consent or interferes with compliance of taking the oral medication
- Clinically significant cardiovascular disease (i.e., active), for example, uncontrolled hypertension, unstable angina, congestive heart failure, class II or higher of the New York Heart Association (NYHA), severe cardiac arrhythmia
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
- Patients subjected to organ allografts who require immunosuppressive treatment.
- Severe, non-cicatrized osseous fractures, wounds or ulcers.
- Indications of hemorrhagic diathesis or coagulopathy.
- Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
- Moderate or severe renal failure [creatinine clearance lower than 30 ml/min (calculated according to the Cockcroft-Gault Formula)] or serum creatinine > 1.5 x upper limit of normal (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.
- ALS 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 dihidropyrimidine dehydrogenase (DPD) deficiency.
- Patients subjected to major surgical procedure, open biopsy or patients have been significant traumatic injures in 28 days time before the initial study treatment, or patients with a major surgery procedure planning during the study period. Fine needle aspiration biopsy 7 days before the initial study.
- Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the initial 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 (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases).
- Pregnant (serum positive pregnancy test) or lactating women.
- Received any investigational drug or agent/ procedure, i.e. participation in another treatment trial within 30 days of randomisation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Treatment will be given until disease progression or unacceptable toxicity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival (PFS)
Time Frame: 2009-2012
|
2009-2012
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival (SG)
Time Frame: 2009-2012
|
2009-2012
|
Overall Response rate
Time Frame: 2009-2012
|
2009-2012
|
Toxicity
Time Frame: 2009-2012
|
2009-2012
|
Duration of response
Time Frame: 2009-2012
|
2009-2012
|
Quality of life
Time Frame: 2009-2012
|
2009-2012
|
Rate of hepatic metastases resection
Time Frame: 2009-2012
|
2009-2012
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Pilar García Alfonso, MD, Hospital Gregorio Marañón. Madrid. Spain
- Study Chair: Enrique Aranda, MD; phD, Hospital Reina Sofía. Cordoba. Madrid
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
March 30, 2009
First Submitted That Met QC Criteria
April 2, 2009
First Posted (Estimate)
April 3, 2009
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 31, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Bevacizumab
- Irinotecan
Other Study ID Numbers
- TTD-08-03
- EudraCT number:2008-004688-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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