Preoperative Chemoradiation With Capecitabine and Cetuximab

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00297128
First received: February 27, 2006
Last updated: December 29, 2011
Last verified: December 2011

February 27, 2006
December 29, 2011
October 2005
August 2011   (final data collection date for primary outcome measure)
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma [ Time Frame: descriptive evaluation ] [ Designated as safety issue: Yes ]
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
Complete list of historical versions of study NCT00297128 on ClinicalTrials.gov Archive Site
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status [ Time Frame: description evaluation ] [ Designated as safety issue: No ]
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
Not Provided
Not Provided
 
Preoperative Chemoradiation With Capecitabine and Cetuximab
Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
  • feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
  • collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • Drug: Capecitabine
    825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
    Other Name: Xeloda
  • Drug: Cetuximab
    400mg/m2 week 1, 250mg/m2 week 2-4
    Other Name: Erbitux
Active Comparator: 1
Interventions:
  • Drug: Capecitabine
  • Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18-80
  • bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
  • no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
  • WHO performance status 0-2
  • adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
  • adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
  • adequate renal function (creatinin - not more than 1.5 mg/dl)
  • women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
  • willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
  • life expectancy of at least 3 month
  • signed Informed Consent before recruitment
  • exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

  • former radiotherapy of pelvis or abdomen
  • former chemotherapy
  • any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
  • general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
  • Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
  • florid, serious infections at the time of recruitment
  • legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
  • evidence of lacking cooperation of the patient
  • pregnant or breast feeding women
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00297128
ABCSG R03 (96) / TAKO 06
No
Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
  • Hoffmann-La Roche
  • Merck Gesellschaft mbH, Austria
Principal Investigator: Josef Thaler, MD Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Joerg Tschmelitsch, MD Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Alexander de Vries, MD Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP