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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT01071655
First received: February 15, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX
Drug: BVZ+XELOX
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]
  • % of patients whose disease becomes resectable [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2010-2014 ] [ Designated as safety issue: Yes ]
  • Evaluation of KRAS status as a molecular marker [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Active Comparator: 1
BVZ + XELOX
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071655

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Hoffmann-La Roche
Investigators
Study Chair: Albert Abad Institut Català d'Oncologia.Hospital Universitari Germans Trias i Pujol. Badalona. Spain
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT01071655     History of Changes
Other Study ID Numbers: TTD-09-01(ML25052), 2009-012562-31
Study First Received: February 15, 2010
Last Updated: March 26, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
colorectal cancer
Bevacizumab
Oxaliplatin
Irinotecan
5FU
capecitabine

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Fluorouracil
Irinotecan
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014