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
  Purpose
  • 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

Condition Intervention Phase
Rectal Cancer
Drug: Capecitabine
Drug: Cetuximab
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: Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status [ Time Frame: description evaluation ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2005
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297128

Locations
Austria
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, Austria, 6020
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, Austria, 4010
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Medical University of Vienna, Radiotherapy
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00297128     History of Changes
Other Study ID Numbers: ABCSG R03 (96) / TAKO 06
Study First Received: February 27, 2006
Last Updated: December 29, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
pilot study
rectal
cancer
phase II
preoperative
chemoradiation
capecitabine
cetuximab
operable
T4
ABCSG
TAKO
R03
96
06

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
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014