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Trial record 73 of 435 for:    colon cancer AND Capecitabine AND colon cancer

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 (SETICC)

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ClinicalTrials.gov Identifier: NCT01071655
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : March 24, 2015
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Tracking Information
First Submitted Date  ICMJE February 15, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
progression-free survival [ Time Frame: 2010-2014 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01071655 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • overall survival [ Time Frame: 2010-2014 ]
  • Objective response rate [ Time Frame: 2010-2014 ]
  • % of patients whose disease becomes resectable [ Time Frame: 2010-2014 ]
  • Adverse events [ Time Frame: 2010-2014 ]
  • Evaluation of KRAS status as a molecular marker [ Time Frame: 2010-2014 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX

    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

  • Drug: BVZ+XELOX
    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 Arms  ICMJE
  • Experimental: 2

    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.

    Intervention: Drug: BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX
  • Active Comparator: 1
    BVZ + XELOX
    Intervention: Drug: BVZ+XELOX
Publications * Abad A, Martínez-Balibrea E, Viéitez JM, Alonso-Orduña V, García Alfonso P, Manzano JL, Massutí B, Benavides M, Carrato A, Zanui M, Gallego J, Grávalos 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
195
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
180
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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:

    1. Absolute neutrophil count (ANC) < 1.5 x 109/l
    2. Platelet count < 100 x 109/l
    3. Hemoglobin < 10 g/dl (it can be transfused to maintain or exceed this level)
    4. International Normalized Ratio (INR) > 1.5
    5. Total bilirubin > 1.5 times the upper limit of normal (ULN)
    6. ALAT, ASAT > 2.5 x ULN or > 5 x (ULN) in the case of hepatic metastases
    7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071655
Other Study ID Numbers  ICMJE TTD-09-01(ML25052)
2009-012562-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study Sponsor  ICMJE Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Chair: Albert Abad Institut Català d'Oncologia.Hospital Universitari Germans Trias i Pujol. Badalona. Spain
PRS Account Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP