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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Grupo de Investigacao do Cancro Digestivo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Grupo de Investigacao do Cancro Digestivo
ClinicalTrials.gov Identifier:
NCT00215722
First received: September 20, 2005
Last updated: April 5, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Grupo de Investigacao do Cancro Digestivo:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 45
Study Start Date: July 2005
Estimated Study Completion Date: July 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215722

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

No publications provided

ClinicalTrials.gov Identifier: NCT00215722     History of Changes
Other Study ID Numbers: GICR-P003
Study First Received: September 20, 2005
Last Updated: April 5, 2007
Health Authority: Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014