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

NCT00215722 | Unknown Phase 2

• 1 other identifier: GICR-P003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

Cetuximab DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo de Investigacao do Cancro Digestivo: lead

Study Sites (10)

Hospital Garcia de Orta

Almada, 2800, Portugal

Location

Hospital Distrital do Barreiro

Barreiro, 2830, Portugal

Location

Hospital Distrital de Beja

Beja, 7800-309, Portugal

Location

Hospital de São Marcos

Braga, 4700, Portugal

Location

Hospitais da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

IPO - Coimbra

Coimbra, 3000, Portugal

Location

Centro Hospitalar do Funchal

Funchal, 9000-514, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, 4454-509, Portugal

Location

Hospital do Divino Espírito Santo

Ponta Delgada, 9500-370, Portugal

Location

IPO - Porto

Porto, 4200, Portugal

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Evaristo Sanches, MD

  Grupo de Investigação do Cancro Digestivo

  PRINCIPAL INVESTIGATOR

• Sérgio Barroso, MD

  Grupo de Investigação do Cancro Digestivo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2008
• Last Updated: April 6, 2007

Record last verified: 2007-04

Locations

PT (10)