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Colorectal CancerPhase 2SETICCNCT01071655

Selecting Treatment in Colorectal Cancer:Capecitabine or 5-fluorouracil Selection to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer

A Phase 2 study testing BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX and BVZ+XELOX in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the efficacy and safety of the capecitabine or 5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX and BVZ+XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteSpain
Study dates
Feb 2010to Nov 2013
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

  • informed consent signed
  • Histological or citological adenocarcinoma confirmation carcinoma on the colon or colorectal metastatic or relapsed patients with adenocarcinoma of colon or recto, confirmed histologically with metastatic disease
  • measurable disease (following RECIST criteria)
  • ECOG ≤ 2
  • older or equal 18 years old
  • life expectancy superior to 3 months
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  • Adequate or moderate renal function: renal function (Creatinine clearance > 30mL/min), based on Cockroff - Gault.
  • Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given
  • Use an adequate contraceptive method

Who cannot join

  • Patients treated previously with Bevacizumab
  • Non measurable lesion as only disease evidence
  • Previous chemotherapy treatment for adjuvant or neoadjuvant disease (no metastatic (M0), or immunotherapy active/passive for the advance or metastatic disease. It is permitted the adjuvant or neoadjuvant treatment it is has finished at least 6 months before the initiation of the study drug.If the patient has received an adjuvant treatment previously the patient cannot participate if disease progression has been confirmed during the treatment or on the 6 months later
  • 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
  • Functional dependency
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  • Previous serious adverse events or unexpected to fluoropyrimidine treatment and /o patients with proved deficit in dehidropirimidin dehydrogenase (DPD)
  • Patients classified as "weak or fragile"
  • Cardiac concomitant present: Symptomatic auriculoventricular arrhythmia history, and / cardiac arrhythmias requiring 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 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 in the physical examination.
  • 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.
  • Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease: CVA/stoke (≤ 6 months prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association (NYHA,) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
  • Patients subjected to organ allograft 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.
  • Any of the following laboratory values:
  • Absolute neutrophil count (ANC) < 1.5 x 109/l
  • Platelet count < 100 x 109/l
  • Hemoglobin < 10 g/dl (it can be transfused to maintain or exceed this level)
  • International Normalized Ratio (INR) > 1.5
  • Total bilirubin > 1.5 times the upper limit of normal (ULN)
  • ALAT, ASAT > 2.5 x ULN or > 5 x (ULN) in the case of hepatic metastases
  • Alkaline phosphatase > 2.5 x ULN or > 5 x ULN in the case of hepatic metastases or > 10 x ULN in the case of osseous metastases.
  • Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study.
  • Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.5.
  • Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases).
  • Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study.
  • Pregnancy or lactating woman. Woman with reproductive potential unless using an effective method of contraception (Postmenopausal woman must have been amenorrheic during at least 12 months).
  • Known hypersensitivity to any of the study drugs or excipients of the Bevacizumab or to Chinese hamster ovary cell products or to other recombinant human or humanised antibodies.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

Official title: Selecting Treatment in Colorectal Cancer: Capecitabine or 5-fluorouracil Selection According to Polymorphisms in TS-3'UTR and ERCC1-118 to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer

The purpose of the study is to evaluate the efficacy and safety of the capecitabine or 5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal cancer

Being tested
BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX, BVZ+XELOX
Keywords
colorectal cancer, Bevacizumab, Oxaliplatin, Irinotecan, 5FU, capecitabine
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOXDrug

    BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1

    BVZ + XELIRI. Bevacizumab 7,5 mg/kg day 1; Capecitabine 800 mg/m2/12 h days 1-14; Irinotecan 200 mg/m2 day 1

    BVZ + FUIRI. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Irinotecan 80 mg/m2 weekly

    BVZ + FUOX. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Oxaliplatin 85 mg/m2 biweekly

  • BVZ+XELOXDrug

    BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1

Study groups in NCT01071655
Study groupRoleWhat they receive
2ExperimentalPatients with zero favorable genotype: BVZ + XELIRI. Patients with one favorable genotype: TS 3'UTR +6bp/+6bp and ERCC1-118 T/T: BVZ + XELOX or TS 3'UTR +6bp/-6bp and ERCC1-118 C/T ó C/C: BVZ + FUIRI. Patients with two favorable genotypes : BVZ + FUOX.
Receives: Drug: BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX
1Active comparatorBVZ + XELOX
Receives: Drug: BVZ+XELOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    Measured: 2010-2014

Secondary outcomes (5)

  1. overall survival

    Measured: 2010-2014

  2. Objective response rate

    Measured: 2010-2014

  3. % of patients whose disease becomes resectable

    Measured: 2010-2014

  4. Adverse events

    Measured: 2010-2014

  5. Evaluation of KRAS status as a molecular marker

    Measured: 2010-2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01071655
Sponsor's protocol ID
TTD-09-01(ML25052)
Other IDs
2009-012562-31, 2009
Acronym
SETICC
Status last verified
Mar 2014
First submitted
15 Feb 2010
Last updated
24 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Abad A, Martinez-Balibrea E, Vieitez JM, Alonso-Orduna V, Garcia Alfonso P, Manzano JL, Massuti B, Benavides M, Carrato A, Zanui M, Gallego J, Gravalos C, Conde V, Provencio M, Valladares-Ayerbes M, Salazar R, Sastre J, Montagut C, Rivera F, Aranda E. Genotype-based selection of treatment of patients with advanced colorectal cancer (SETICC): a pharmacogenetic-based randomized phase II trial. Ann Oncol. 2018 Feb 1;29(2):439-444. doi: 10.1093/annonc/mdx737.

    PubMed 29145602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX and BVZ+XELOX in people with 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 9 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 24 Mar 2015. 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 (time frame: 2010-2014). 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 NCT01071655, 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 24 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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