Phase II Study of Neo Adjuvant Treatment With Avastin, Xeloda and/or Eloxatin in Colorectal Cancer (AXE BEAM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00828672
First received: January 23, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).


Condition Intervention Phase
Advanced Colorectal Cancer
Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine
Radiation: radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Pathologic complete response (ypT0N0) rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histopathologic R0 and negative CRM resection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pathologic downstaging (yp T0-2 N0) rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Tumor regression grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Clinical response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: continuous up to 1 year ] [ Designated as safety issue: Yes ]
  • Loco-regional and distant recurrence rates [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
Drug: Oxaliplatin
Administered on days 15,22,29,36 en 43; 50 mg/m2
Other Name: Eloxatin
Drug: Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Other Name: Avastin
Drug: Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
Other Name: Xeloda
Radiation: radiotherapy
Total dose 45Gy
Other Name: Radiotherapy
Active Comparator: AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
Drug: Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Other Name: Avastin
Drug: Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
Other Name: Xeloda
Radiation: radiotherapy
Total dose 45Gy
Other Name: Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is at least 18 years of age
  • Good organ function
  • Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum

Exclusion Criteria:

  • Evidence of distant metastases
  • Contraindication for bevacizumab
  • Pregnant or breastfeeding women.
  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: NCT00828672

Locations
Belgium
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
ZNA Middelheim
Antwerp, Belgium, ZNA Middelheim
AZ St- Lucas
Brugge, Belgium, 8310
Erasme Hospital
Brussels, Belgium, 1070
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Salvator Ziekenhuis
Hasselt, Belgium, 3500
AZ Groeninge
Kortrijk, Belgium, 8500
C.H.U. Sart-Tilman
Liege, Belgium, 4000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
H. Hartziekenhuis
Roeselare, Belgium, 8800
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Eric Van Cutsem, Prof. Dr. UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00828672     History of Changes
Other Study ID Numbers: s51104 - ML5194, 2007 - 007177 - 23, MO19051
Study First Received: January 23, 2009
Last Updated: December 17, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
assess activity
bevacizumab
capecitabine
radiation therapy
oxaliplatin
pre-operative treatment
TME (total mesorectal excision).

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014