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: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer
Conditions
Interventions
Trade Name: GLIVEC*120CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name:
Sponsors
Azienda Ospedaliera Universitaria S.Martino - U.O. Oncologia Medica - Genova
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: High complete response rate 25 defined as complete disappearance of all signs and symptoms of the disease as well as no imaging CT and serologic CEA evidence of disease.;Secondary Objective: Partial response rate; Progression free survival; of patients whose disease becomes radically respectable; Overall survival; Tolerability; Time to treatment failure; Time to treatment discontinuation; Potential correlations between activity and Circulating endothelial cells, Circulating endothelial precursor cells, C-kit expression by IHC;Primary end point(s): We aim at a high rate of sustained CR 25 lasting a minimum of 12 months . If we could show a 25 CR rate in the setting, no matter how selected the patients are as long as they have non resectable metastases at presentation , anybody should agree that this approach should be further pursued. There are 2 components to this endpoint - the high rate of CR - and the very long minimal duration of the achieved CR at least 12 mo . We fully realize that this is very ambitious goal. The CR rate to CT alone in these setting is below 5 and the R0 resectability rate in advanced CRC is in the range of 10 . The median duration of NED state following R-0 resection, i.e. the DFS, varies according to the starting conditions, but the most reliable figure for patients with initially non respectable liver mets is around 6 months S. Alberts, Mayo, 2006, n 40 patients . This in general should be regarded too short a figure to make a liver resection acceptable. The cost of medical treatment plan under investigation is prohibitive. If all 3 biologics plus CT are regularly taken, the cost of the drugs hospital pharmacy cost is around 9000 per month. And if we count an average of 15.000 for the liver resection, the entire treatment plan for 6 months of medical treatment plus the cost of surgery is in the range of 70.000 per patient. This figure is so high that anything below the threshold we identif | — |
Countries
Italy
Outcome results
None listed