XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer

April 5, 2007 updated by: Grupo de Investigacao do Cancro Digestivo

The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.

This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The phase II trials with XELOX, demonstrated that is a highly effective first-line treatment for metastatic colorectal cancer, with response rates similar to the regimens with oxaliplatin and infusional 5-FU/LV (FOLFOX), but more convenient and likely to be preferred by both patients and health care providers.

Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease which suggests that a much greater degree of benefit may ensue when it is used at an earlier stage of the disease course.

The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.

This study is aimed at establishing the efficacy and safety of the combination cetuximab/XELOX as first line therapy in patients with MCRC.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Almada, Portugal, 2800
        • Hospital Garcia de Orta
      • Barreiro, Portugal, 2830
        • Hospital Distrital do Barreiro
      • Beja, Portugal, 7800-309
        • Hospital Distrital de Beja
      • Braga, Portugal, 4700
        • Hospital de São Marcos
      • Coimbra, Portugal, 3000-075
        • Hospitais da universidade de Coimbra
      • Coimbra, Portugal, 3000
        • IPO - Coimbra
      • Funchal, Portugal, 9000-514
        • Centro Hospitalar do Funchal
      • Matosinhos, Portugal, 4454-509
        • Hospital Pedro Hispano
      • Ponta Delgada, Portugal, 9500-370
        • Hospital do Divino Espírito Santo
      • Porto, Portugal, 4200
        • IPO - Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent, prior any study-specific procedures
  • Male or female > = 18 years of age
  • Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease not eligible for surgery with curative intent - in case of a unique metastatic lesion this should be confirmed by biopsy
  • ECOG performance status < 1 at study entry
  • Immunohistochemical evidence of EGFR expression on tumour tissue
  • Presence of at least one unidimensional measurable lesion with a diameter > 20mm by conventional CT scan or MRI, and 10mm by spiral CT scan, according to the RECIST criteria (Index lesion(s) must not lie within an irradiated area)
  • Have not received any Chemotherapy regimen for metastatic disease
  • Life expectancy of > 3 months
  • Neutrophils > = 1.5 x 109/L, platelet count > = 100 x 109/L, and haemoglobin > = 9 g/dL.
  • Bilirubin level either normal or 1.5 x ULN
  • ASAT and ALAT < = 2.5 x ULN (< = 5 x ULN in case of liver metastasis)
  • Alkaline phosphatase < = 2.5 x ULN or < = 5 x ULN in case of liver metastasis or < = 10 x ULN in case of bone metastases
  • Serum creatinine < = 1.5 x ULN or CrCl > 50 ml/min (Cockroft and Gault formula)
  • Negative Pregnancy test within one week before treatment start, if applicable

Exclusion Criteria:

  • Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan.
  • Adjuvant or neo-adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months and the patient have not progressed during treatment
  • Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
  • Prior radiotherapy is permitted if it was not administered to target lesions selected for this study
  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to entry
  • Previous exposure to EGFR-pathway targeting therapy
  • History of evidence upon physical examination of CNS disease (e.g. primary brain tumour, seizure not controlled with standard therapy, any brain metastasis or history of stroke)
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
  • Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
  • Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  • Pre-existing neuropathy > grade 1
  • Known grade 3 or 4 allergic reaction to any of the components of the treatment.
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > = 5 years will be allowed to enter the trial)
  • Known drug abuse/ alcohol abuse
  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
  • Pregnant or lactating women
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
  • Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
  • Known dihydropyrimidine dehydrogenase deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the Efficacy of the combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy based on the overall response rate (ORR) according to the RECIST criteria.

Secondary Outcome Measures

Outcome Measure
Determine the Safety parameters of combination treatment (cetuximab plus capecitabine and oxaliplatin) as first-line therapy analyzing the frequency, severity, duration and relationship of adverse events using the NCI CTCAE, version 3.0
Time to tumour progression (TTP)
Overall survival time (OS)
Evaluate the Quality of Life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigacao do Cancro Digestivo

Investigators

  • Principal Investigator: Evaristo Sanches, MD, Grupo de Investigação do Cancro Digestivo
  • Principal Investigator: Sérgio Barroso, MD, Grupo de Investigação do Cancro Digestivo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 6, 2007

Last Update Submitted That Met QC Criteria

April 5, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICR-P003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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