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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol Multidisciplinario del Cancer Digestivo
ClinicalTrials.gov Identifier:
NCT01067053
First received: January 21, 2010
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: bevacizumab, capecitabine, oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of treatment cycles administered [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of patients who have required dose reductions of either drug [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety of treatment according to the number of adverse events reported [ Time Frame: 3 yeras ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 69
Study Start Date: November 2009
Estimated Study Completion Date: March 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067053

Locations
Spain
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 Quirón de Madrid
Madrid, Spain, 28223
Hospital Universitario la Paz
Madrid, Spain, 28046
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Doctor Peset
Valencia, Spain, 46017
Hospital La Fe de Valencia
Valencia, Spain, 46009
Hospital Xeral Cies de Vigo
Vigo, Spain, 36204
Sponsors and Collaborators
Grupo Espanol Multidisciplinario del Cancer Digestivo
Investigators
Study Chair: Jaime Feliu Batlle, MD Grupo Español Multidisciplinario de Cáncer Digestivo
  More Information

No publications provided

Responsible Party: Grupo Espanol Multidisciplinario del Cancer Digestivo
ClinicalTrials.gov Identifier: NCT01067053     History of Changes
Other Study ID Numbers: GEMCAD-0901
Study First Received: January 21, 2010
Last Updated: January 8, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:
Bevacizumab
Capecitabine
Oxaliplatin
Metastatic colorectal cancer

Additional relevant MeSH terms:
Adenocarcinoma
Colorectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Bevacizumab
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on April 17, 2014