Preoperative Chemoradiation With Capecitabine and Cetuximab

NCT00297128 | Completed Phase 2

• 1 other identifier: ABCSG R03 (96) / TAKO 06
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 10

Brief Summary

• 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

Conditions

Rectal Cancer

Keywords

pilot study; rectal; cancer; phase II; preoperative; chemoradiation; capecitabine; cetuximab; operable; T4; ABCSG; TAKO; R03; 96; 06

Outcome Measures

Primary Outcomes (1)

• feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma

  descriptive evaluation

Secondary Outcomes (1)

• collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status

  description evaluation

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: Capecitabine; Drug: Cetuximab

Interventions

Capecitabine DRUG

825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

Also known as: Xeloda

1

Cetuximab DRUG

400mg/m2 week 1, 250mg/m2 week 2-4

Also known as: Erbitux

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead
• Hoffmann-La Roche: collaborator
• Merck Gesellschaft mbH, Austria: collaborator

Study Sites (10)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, 9330, Austria

Location

Hospital Wiener Neustadt, Surgery

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, 5020, Austria

Location

Medical University of Graz, Oncology

Graz, Styria, 8036, Austria

Location

State Hospital Leoben

Leoben, Styria, 8700, Austria

Location

Medical University of Innsbruck, Surgery

Innsbruck, Tyrol, 6020, Austria

Location

Hospital BHS Linz, Radiooncology

Linz, Upper Austria, 4010, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Medical University of Vienna, Radiotherapy

Vienna, Vienna, 1090, Austria

Location

State Hospital Feldkirch

Feldkirch, Vorarlberg, 6807, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Interventions

Capecitabine; Cetuximab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: February 28, 2006
• Study Start: October 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

AU (10)