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Trial record 91 of 436 for:    colon cancer AND Capecitabine

Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT00335595
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : February 20, 2013
Sponsor:
Collaborators:
Sanofi
Roche Pharma AG
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Tracking Information
First Submitted Date  ICMJE June 9, 2006
First Posted Date  ICMJE June 12, 2006
Last Update Posted Date February 20, 2013
Study Start Date  ICMJE July 2006
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Determine the free time to disease progression [ Time Frame: 2006-2012 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Determinate the free time to disease progression
Change History Complete list of historical versions of study NCT00335595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Overall survival [ Time Frame: 2006-2012 ]
  • Overall response rate [ Time Frame: 2006-2012 ]
  • Time to onset of response [ Time Frame: 2006-2012 ]
  • Duration of response [ Time Frame: 2006-2012 ]
  • Treatment cycles number [ Time Frame: 2006-2012 ]
  • Number of patients who need medicine dose reduction [ Time Frame: 2006-2012 ]
  • adverse events [ Time Frame: 2006-2012 ]
  • Prognostic and predictive factor of Circulating endothelial cells (CEC) and circulating tumors cells (CTC) baseline and after 3 cycle [ Time Frame: 2006-2012 ]
  • Prognostic factor of the K-Ras gene mutation [ Time Frame: 2006-2012 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
  • Overall survival
  • Overall response rate
  • Time to onset of response
  • Duration of response
  • Treatment cycles number
  • Number of patients who need medicine dose reduction.
  • Safety of the treatments, depending on number and kind of reported Adverse Events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients
Official Title  ICMJE Randomized, Multicenter, Phase III Study, to Evaluate the Efficacy and Safety of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy After Initial Chemotherapy Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients
Brief Summary The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.
Detailed Description The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: XELOXA
    XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks
  • Drug: XELOXA-A

    XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study.

    One cycle every 3 weeks

Study Arms  ICMJE
  • Active Comparator: 1
    XELOXA
    Intervention: Drug: XELOXA
  • Experimental: 2
    XELOXA-A
    Intervention: Drug: XELOXA-A
Publications *

*   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: February 18, 2010)
480
Original Enrollment  ICMJE
 (submitted: June 9, 2006)
470
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent given.
  • Patients who are able to understand the study request.
  • Men and women > or = 18 years, not hospitalized.
  • Outpatients with ECOG performance status ≤ 2.
  • Histologically confirmed diagnosis of colorectal cancer (CRC) patients with metastasis.
  • Presence of at least one detectable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Life expectancy of greater than 3 months.
  • Men and women potentially fertile using an effective contraceptive method

Exclusion Criteria:

  • Patients who have been treated with bevacizumab previously.
  • Received any systemic treatment previously to treat an advanced or metastatic disease

    • Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that it has been finished at least 6 months before the initial study treatment.
    • If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during treatment or for 6 months after the end of treatment.
    • If radiotherapy has not been administered in the lesion selected for the study, previous radiotherapy is allowed, unless progression of those injuries can be documented in the radiated field, as long as the end of the treatment has been finished at least 4 weeks before study initiation.
    • Previous surgical procedure of stage IV disease is allowed.
  • Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or this study indication, unless there has been a disease-free interval of at least 2 years.
  • History or evidence upon physical examination of central nervous system
  • History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • Clinically significant cardiovascular disease (active).
  • Patients who have undergone myocardial infarction or cerebrovascular accident 6 months prior to randomisation will be excluded.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medications.
  • Patients subjected to allogeneic transplant and request immunotherapy.
  • Bone fracture not healed, wounds or severe ulcers.
  • Known hemorrhagic diathesis or coagulopathy.
  • Uncontrolled and severe intercurrent infections or other severe and uncontrolled concomitant diseases.
  • Moderate or severe renal impairment (creatinine clearance < 30 ml/min [calculated according to Cockroft-Gault formula] or serum creatinine ≥ 2 mg/dl or 177 μmol/l).
  • Any of the following laboratory values:

    • Absolute neutrophil count (ANC) ≤ 1.5 x 10^9/l.
    • Platelet count ≤ 100 x 10^9/l.
    • Hemoglobin ≤ 9 g/dl.
    • International Normalized Ratio (INR) ≥ 1.5.
    • Total bilirubin ≥ 1.5 x upper limit of normal (ULN).
    • ALT 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 dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patients subjected to major surgical procedure or open biopsy; or patients have had significant traumatic injuries 28 days before the initial study treatment; or patients with a major surgical procedure planned during the study period.
  • Fine needle aspiration biopsy 7 days before study initiation.
  • 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.
  • Subjects requiring chronic use of high dose aspirin (> 325 mg/day) or non-steroidal anti-inflammatory treatment (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases).
  • Pregnant or lactating women.
  • Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies; or to any excipients of bevacizumab formulation; or to any other study drugs.
  • Received any investigational drug or agent/procedure, i.e. participation in another treatment trial within 30 days of randomisation.
  • Evidence of another disease, metabolic malfunction, discovery in a physical examination or in a clinical laboratory test to result in reasonable suspicion of a condition or disease that contraindicates investigational medicine use or exposes the patient to high risk treatment complications.
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 NCT00335595
Other Study ID Numbers  ICMJE TTD-05-02
EudraCT Nº: 2005-003325-67
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
  • Sanofi
  • Roche Pharma AG
Investigators  ICMJE
Study Chair: Enrique Aranda, MD; phD Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
Study Chair: Eduardo Díaz-Rubio, MD; phD Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
PRS Account Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Verification Date February 2013

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