Xeloda and Bevacizumab to Treat Rectal Cancer (xeberecto)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT00847119
First received: February 18, 2009
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.


Condition Intervention Phase
Rectal Cancer
Biological: Bevacizumab
Drug: capecitabine (Xeloda)
Radiation: Rectal Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) [ Time Frame: Surgery date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall clinical response [ Time Frame: Surgery date ] [ Designated as safety issue: No ]
  • To determine the downstaging caused by treatment [ Time Frame: Surgery date ] [ Designated as safety issue: No ]
  • relapse free survival [ Time Frame: Time of radiological evidence of relapse. ] [ Designated as safety issue: No ]
  • Quantify the local control grade: R0 resections in surgery [ Time Frame: Surgery date ] [ Designated as safety issue: No ]
  • Local relapse and distant relapse rates [ Time Frame: Relapse date ] [ Designated as safety issue: No ]
  • To determine the security profile of this neoadjuvant treatment (radio- chemotherapy) [ Time Frame: From date of register to surgery date ] [ Designated as safety issue: Yes ]
  • Surgery complication rate [ Time Frame: During surgery admission. ] [ Designated as safety issue: Yes ]
  • To determine the angiogenic profile changes in tumour. [ Time Frame: 15 days, 6 weeks and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab & capecitabine & radiotheraphy

Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.

Biological: Bevacizumab
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Drug: capecitabine (Xeloda)
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
Radiation: Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has given written informed consent prior to any study related procedure
  2. Male and female aged 18 to 75 years
  3. ECOG performance status 0 or 1
  4. Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
  5. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
  6. Disease evaluable by imaging techniques
  7. No tumour haemorrhage in the week prior to start of study treatment
  8. External derivation in symptomatic occlusive tumours
  9. Not prior cancer treatment
  10. Adequate bone marrow, hepatic and renal function, defined as:

    1. White blood cells ≥ 4 x 109 /l
    2. Absolute neutrophil count ≥ 1.5 x 109 /l
    3. Platelets ≥ 100 x 109 /l
    4. Haemoglobin ≥10 g/dl
    5. Bilirubin < 1.25 x upper limit of normal
    6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
    7. Serum creatinine ≤ 106 µmol/l
  11. Less than 10% weight loss

Exclusion Criteria:

  1. Rectal cancer no amenable to resection
  2. Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
  3. Pregnant or breast-feeding women
  4. Women oh childbearing potential unless effective methods of contraception are used
  5. No prior or concurrent significant medical conditions, including any of the following:

    • Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
    • Cardiovascular disease, including the following:
    • Myocardial infarction within the past year
    • Uncontrolled hypertension while receiving chronic medication
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
  6. Major trauma within the past 28 days
  7. Serious nonhealing wound, ulcer, or bone fracture
  8. Evidence of bleeding diathesis or coagulopathy
  9. No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
  10. No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
  11. No known dihydropyrimidine dehydrogenase deficiency
  12. Major surgery in the 4 weeks prior to the start of study treatment
  13. No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
  14. More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
  15. No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
  16. No other medical history or condition that, in the opinion of the investigator, would preclude study participation
  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: NCT00847119

Locations
Spain
Institut Català d'Oncologia-L'Hospitalet
L'Hospitalet del Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Institut Català d'Oncologia
Hoffmann-La Roche
Investigators
Principal Investigator: Ramon Salazar, Phd Institut Català d'Oncologia
Study Chair: Margarita Garcia, MD Institut Català d'Oncologia
  More Information

Publications:
PHASE II STUDY OF PREOPERATIVE BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR RESECTABLE LOCALLY ADVANCED RECTAL CANCER. M. Martinez Villacampa, C. Santos, M. García, V. Navarro, A. Teule, F. Losa, A. Pisa, L. Lema, S. Biondo, R. Salazar. J Clin Oncol 29: 2011 (suppl 4; abstr 516)

Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT00847119     History of Changes
Other Study ID Numbers: ML 20006. XEBERECTO/ICO/005, EudraCT number:2007-000456-13
Study First Received: February 18, 2009
Last Updated: June 19, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Institut Català d'Oncologia:
rectum
adenocarcinoma
neoadjuvant
bevacizumab
capecitabine
radiotherapy
locally
advanced
resectable
resectable locally advanced adenocarcinoma of the rectum
xeberecto

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014