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

• Status: Unknown status
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo de Investigacao do Cancro Digestivo
• Treatments: Cetuximab

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