Status:
UNKNOWN
XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Grupo de Investigacao do Cancro Digestivo
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 infusion...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00215722
Start Date
July 1 2005
End Date
July 1 2008
Last Update
April 6 2007
Active Locations (10)
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1
Hospital Garcia de Orta
Almada, Portugal, 2800
2
Hospital Distrital do Barreiro
Barreiro, Portugal, 2830
3
Hospital Distrital de Beja
Beja, Portugal, 7800-309
4
Hospital de São Marcos
Braga, Portugal, 4700