Colorectal cancer with initially irresectable liver-only metastases
Conditions
Interventions
Trade Name: Vectibix
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Concentration unit: mg/l milligram(s)/litre
Concentration type:
Sponsors
Dutch Colorectal Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven colorectal cancer - Irresectable metastases confined to the liver according to CT scan, obtained = 4 weeks prior to randomization. Irresectability should be confirmed by the panel. Patients with small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible. - Adequate tumor tissue available for central assessment of RAS/BRAF mutation status - WHO performance status 0-2 (Karnofsky performance = 70) - Age = 18 years - No contraindications for liver surgery - in case of synchronous metastatses: resectable primary tumor, or adequate clinical recovery in case of immediate surgery of primary tumor - Adequate organ functions, as determined by normal bone marrow function (Hb ³ 6.0 mmol/L, absolute neutrophil count ³ 1.5 x 109/L, platelets ³ 100 x 109/L), renal function (serum creatinine = 1.5x ULN and creatinine clearance, Cockroft formula, ³ 30 ml/min), liver function (serum bilirubin = 2 x ULN, serum transaminases = 5x ULN) - Life expectancy > 12 weeks - Expected adequacy of follow-up - Written informed consent 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 292 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292
Exclusion criteria
Exclusion criteria: - Extrahepatic metastases, with the exception of small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases - Irresectable primary tumor, or resectable tumor requiring immediate surgery - Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery) - Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months of randomization - Uncontrolled hypertension, or unsatisfactory blood pressure control with =3 antihypertensive drugs - Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed = 6 months prior to randomization - Previous intolerance of study drugs in the adjuvant setting - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study in metastatic CRC patients with initially irresectable liver-only metastases are to determine the median progression-free survival (PFS) (primary objective) and R0/1 secondary resection rate (secondary objective) in each of the 3 study arms upon neoadjuvant treatment with chemotherapy plus targeted therapy. ;Secondary Objective: Other secondary objectives are to assess the median overall survival, response rate, toxicity, pathological complete response rate (pCR) of resected lesions, and postoperative morbidity. Translational research will be performed on predictive/prognostic biomarkers and imaging methods. ;Primary end point(s): progression free survival (PFS) and R0/1 resection rate,;Timepoint(s) of evaluation of this end point: Two interim analyses and a final analysis will be performed, equally spaced based on the number of events (approximately at one-third, two-third) of the way through the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): median overall survival, 3- and 5-year overall survival rates, tumor response rate, toxicity, pathological complete response rate (pCR) of resected lesions, and postoperative morbidity. ;Timepoint(s) of evaluation of this end point: Two interim analyses and a final analysis will be performed, equally spaced based on the number of events (approximately at one-third, two-third) of the way through the trial. | — |
Countries
Netherlands
Contacts
Public ContactClinical research department
IKNL
Outcome results
None listed