NCT01071655

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Feb 2010

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2014

Enrollment Period

3.8 years

First QC Date

February 15, 2010

Last Update Submit

March 23, 2015

Conditions

Colorectal Cancer

Keywords

colorectal cancerBevacizumabOxaliplatinIrinotecan5FUcapecitabine

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2010-2014

Secondary Outcomes (5)

  • overall survival

    2010-2014

  • Objective response rate

    2010-2014

  • % of patients whose disease becomes resectable

    2010-2014

  • Adverse events

    2010-2014

  • Evaluation of KRAS status as a molecular marker

    2010-2014

Study Arms (2)

2

EXPERIMENTAL

Patients 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.

Drug: BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX

1

ACTIVE COMPARATOR

BVZ + XELOX

Drug: BVZ+XELOX

Interventions

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

2
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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, 28046, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29145602DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Albert Abad

    Institut Català d'Oncologia.Hospital Universitari Germans Trias i Pujol. Badalona. Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 19, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 24, 2015

Record last verified: 2014-03

Locations

ES(1)