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Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer (XERT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier:
NCT00689702
First received: May 30, 2008
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.


Condition Intervention Phase
Rectal Cancer
 Drug: cetuximab, capecitabine
 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: Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:
  • Complete pathological remission rate [ Time Frame: at pathological examm of surgical speciment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of sphincter sparing surgical procedure Toxicity/safety [ Time Frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: February 2007
Estimated Study Completion Date: May 2013
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cetuximab, capecitabine

    Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50).

    Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy.

    Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.

    Other Names:
    • Erbitux
    • Xeloda
Detailed Description:

Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.

  Eligibility

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

Inclusion Criteria:

  • Age 18 to 80 if judged fit for surgery
  • WHO performance status 0-1
  • Histologically proven rectal adenocarcinoma located below the peritoneum
  • T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
  • No distant metastases
  • Adequate haematological, cardiac, liver and renal function
  • Signed informed consent
  • Appropriate measures for contraception for men and women, if applicable

Exclusion Criteria:

  • Prior radio- and/or chemotherapy
  • Others synchronous cancers
  • History of other malignant disease
  • Significant heart disease
  • Known hypersensitivity to biological drugs
  • Pregnant or lactating patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689702

Locations
Slovenia
Institute of Oncology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
Investigators
Principal Investigator: Vaneja Velenik, PhD, MD Institute of Oncology, Ljubljana, Slovenia
  More Information

Publications:

Responsible Party: Vaneja Velenik, PhD, MD,, Institute of Oncology Ljubljana, Slovenia
ClinicalTrials.gov Identifier: NCT00689702     History of Changes
Other Study ID Numbers: EMR 62202-688
Study First Received: May 30, 2008
Last Updated: March 23, 2012
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee

Keywords provided by Institute of Oncology Ljubljana:
cetuximab
capecitabine
radiotherapy
rectal cancer

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 May 16, 2013