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Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients. (BECOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067053
Recruitment Status : Unknown
Verified January 2014 by Grupo Espanol Multidisciplinario del Cancer Digestivo.
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2010
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
Grupo Espanol Multidisciplinario del Cancer Digestivo

Brief Summary:
The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: bevacizumab, capecitabine, oxaliplatin Phase 2

Detailed Description:

The efficacy will be determined by objective response rate following RECIST criteria.

In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.

This clinical trial includes 3 substudies:

- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.

Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.

-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.

Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.

-Characterization of resistance to bevacizumab in colon cancer in elderly patients.

Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: bevacizumab, capecitabine, oxaliplatin

6 cycles (3 weeks each one) of:

  • bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle.
  • capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
  • oxaliplatin: 130/mg/m2(iv),1st day of each cycle.

After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Drug: bevacizumab, capecitabine, oxaliplatin

6 cycles (3 weeks each one) of:

  • bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle.
  • capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
  • oxaliplatin: 130/mg/m2(iv),1st day of each cycle.

After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Other Names:
  • bevacizumab (Avastin®)
  • capecitabine (Xeloda®)
  • oxaliplatin

Primary Outcome Measures :
  1. Time to progression [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: 3 years ]
  3. Overall response rate [ Time Frame: 3 years ]
  4. Number of treatment cycles administered [ Time Frame: 3 years ]
  5. Number of patients who have required dose reductions of either drug [ Time Frame: 3 years ]
  6. Safety of treatment according to the number of adverse events reported [ Time Frame: 3 yeras ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • ECOG 0-1.
  • Age ≥ 70 years.
  • Histologically confirmed carcinoma of the colon and/or rectum.
  • Metastatic disease non suitable for radical surgery.
  • At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
  • Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.
  • Life expectancy more than 3 months.
  • Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
  • Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
  • Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
  • Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
  • No clinical evidence or history of metastatic CNS disease.
  • No prior Bevacizumab treatment.

Exclusion Criteria:

  • Patients who previously received bevacizumab.
  • Prior chemotherapeutic treatment for metastatic CRC.
  • Prior treatment with monoclonal antibodies.
  • Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
  • Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
  • Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
  • Intestinal occlusion/subocclusion.
  • Chronic diarrhea.
  • Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
  • Known hypersensitivity to any of the study drugs.
  • Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.
  • Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
  • History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
  • Patients with previous of arterial thromboembolic event.
  • Evidence of bleeding diathesis or coagulopathy.
  • Serious, non healing wound, ulcer, or bone fracture.
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
  • Patients of childbearing potential not willing to use effective means of contraception.
  • Positive HIV serology.
  • Known addiction to alcohol or other drugs.
  • Patients included in other clinical trial

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 identifier (NCT number): NCT01067053

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Hospital de L´Hospitalet
Hospitalet de Llobregat, Barcelona, Spain, 08906
Hospital de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain, 28702
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Lluis Alcanyis
Játiva, Valencia, Spain, 46800
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital General Yagüe
Burgos, Spain, 09005
Hospital Arnau de Vilanova
Lérida, Spain, 25198
Hospital Universitario la Paz
Madrid, Spain, 28046
Hospital Quirón de Madrid
Madrid, Spain, 28223
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital La Fe de Valencia
Valencia, Spain, 46009
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Doctor Peset
Valencia, Spain, 46017
Hospital Xeral Cies de Vigo
Vigo, Spain, 36204
Sponsors and Collaborators
Grupo Espanol Multidisciplinario del Cancer Digestivo
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Study Chair: Jaime Feliu Batlle, MD Grupo Español Multidisciplinario de Cáncer Digestivo

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Responsible Party: Grupo Espanol Multidisciplinario del Cancer Digestivo Identifier: NCT01067053     History of Changes
Other Study ID Numbers: GEMCAD-0901
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:
Metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action