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Trial record 88 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

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)

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: XELOXA Drug: XELOXA-A Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
XELOXA
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

Experimental: 2
XELOXA-A
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





Primary Outcome Measures :
  1. Determine the free time to disease progression [ Time Frame: 2006-2012 ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2006-2012 ]
  2. Overall response rate [ Time Frame: 2006-2012 ]
  3. Time to onset of response [ Time Frame: 2006-2012 ]
  4. Duration of response [ Time Frame: 2006-2012 ]
  5. Treatment cycles number [ Time Frame: 2006-2012 ]
  6. Number of patients who need medicine dose reduction [ Time Frame: 2006-2012 ]
  7. adverse events [ Time Frame: 2006-2012 ]
  8. Prognostic and predictive factor of Circulating endothelial cells (CEC) and circulating tumors cells (CTC) baseline and after 3 cycle [ Time Frame: 2006-2012 ]
  9. Prognostic factor of the K-Ras gene mutation [ Time Frame: 2006-2012 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335595


Locations
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Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Sanofi
Roche Pharma AG
Investigators
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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)

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
ClinicalTrials.gov Identifier: NCT00335595     History of Changes
Other Study ID Numbers: TTD-05-02
EudraCT Nº: 2005-003325-67
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):
colorectal cancer
Bevacizumab
capecitabine
oxaliplatin
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action