Phase II trial FOLFOX combined with Bevacizumab, Cetuximab and Imatinib in patients with advanced untreated colorectal cancer - ND

Conditions: advanced untreated colorectal cancer in disease stage IV for which, second recent line-guide Poston JCO, October 2005 not is indication to the surgical treatment and that they have not been she deals to you in previous with x-ray.
MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancer

Registration Number: EUCTR2006-001779-39-IT

Lead Sponsor: Azienda Ospedaliera Universitaria S.Martino - U.O. Oncologia Medica - Genova

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1 Histologically proven colorectal adenocarcinoma; 2 Stage IV disease for which there is no indication for surgery according to the most recent guidelines Poston JCO October 2005 . In particular, will be considered eligibile patients with a 4 metastases or bilobar involvement, b location of metastases that would preclude resection with tumor-free margins - metastases adjacent or involving all three major hepatic veins, the portal vein bifurcation or the retrohepatic vena cava, -metastases adjacent or involving the main right or main left portal venin and the main hepatic vein of the opposite lobe, - metastases that would require more than a right or left trisegmentectomy; 3 Bidimensionally measurable disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The eligibility criteria are definitely stringent. The major problems in all the phase II studies of preoperative CT in stage IV CRC is that they are done on a category of patients that is not clearly defined those potentially resectable . There is no agreement as to what a potentially resectable tumor is. We select only patients who are clearly non resectable. How do we define the lower threshold of tumor bulk for being eligible We should be very unbiased in selecting clearly unresectable tumors with only one or two metastatic sites in fact we will refer to the oncosurge program on the internet non optimal, but better than anything else and consider eligible for our study only those patients where no expert would advise surgery. How do we define the upper threshold of tumor bulk for being eligible This is more difficult. In the initial version of the protocol we listed the exclusion criteria that the Mayo group has used in their recently reported study of neoadjuvant folfox. However, after talking to the surgeon who reviewed their cases, these criteria were considered too complicate and not so clear cut, when used in practice. Thus we decided to stick to a simpler upper threshold to avoid too many bad actors no peritoneal carcinomatosis and no more than 2 sites of disease.