Metastatic Colorectal CancerPhase 2AVAXIRINCT00875771
Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients
A Phase 2 study testing Capecitabine+Irinotecan+Bevacizumab in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Capecitabine+Irinotecan+Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2009to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid
About this study
Official title: 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.
Read the 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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Capecitabine+Irinotecan+Bevacizumab
- Keywords
- metastatic colorectal cancer, BEVACIZUMAB, CAPECITABINE, IRINOTECAN
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine+Irinotecan+BevacizumabDrug
- 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
Treatment will be given until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * 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 Receives: Drug: Capecitabine+Irinotecan+Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 2009-2012
Secondary outcomes (6)
overall survival (SG)
Measured: 2009-2012
Overall Response rate
Measured: 2009-2012
Toxicity
Measured: 2009-2012
Duration of response
Measured: 2009-2012
Quality of life
Measured: 2009-2012
Rate of hepatic metastases resection
Measured: 2009-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Pilar García Alfonso, MD, Study chair, Hospital Gregorio Marañón. Madrid. SpainEnrique Aranda, MD; phD, Study chair, Hospital Reina Sofía. Cordoba. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875771
- Sponsor's protocol ID
- TTD-08-03
- Other IDs
- EudraCT number:2008-004688-20
- Acronym
- AVAXIRI
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2009
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Alfonso P, Chaves M, Munoz A, Salud A, Garcia-Gonzalez M, Gravalos C, Massuti B, Gonzalez-Flores E, Queralt B, Lopez-Ladron A, Losa F, Gomez MJ, Oltra A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: the phase II AVAXIRI study. BMC Cancer. 2015 Apr 29;15:327. doi: 10.1186/s12885-015-1293-y.
PubMed 25925749
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00875771
- Acronym / sponsor ID
- AVAXIRI / TTD-08-03
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, BEVACIZUMAB, CAPECITABINE, IRINOTECAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Capecitabine+Irinotecan+Bevacizumab* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine+Irinotecan+Bevacizumab* 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 Treatment will be given until disease progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
Progression free survival (PFS)
Time frame: 2009-2012
6 secondary outcomes
overall survival (SG)
Time frame: 2009-2012
Overall Response rate
Time frame: 2009-2012
Toxicity
Time frame: 2009-2012
Duration of response
Time frame: 2009-2012
Quality of life
Time frame: 2009-2012
Rate of hepatic metastases resection
Time frame: 2009-2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 25925749Garcia-Alfonso P, Chaves M, Munoz A, Salud A, Garcia-Gonzalez M, Gravalos C, Massuti B, Gonzalez-Flores E, Queralt B, Lopez-Ladron A, Losa F, Gomez MJ, Oltra A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Capecitabine and irinotecan with bevacizumab 2-weekly for metastatic colorectal cancer: the phase II AVAXIRI study. BMC Cancer. 2015 Apr 29;15:327. doi: 10.1186/s12885-015-1293-y.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar García Alfonso, MD study chair
Hospital Gregorio Marañón. Madrid. Spain
Enrique Aranda, MD; phD study chair
Hospital Reina Sofía. Cordoba. Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine+Irinotecan+Bevacizumab in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 2009-2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.