previously untreated, wild-type RAS, potentially resectable colorectal cancer liver metastases
Conditions
Interventions
Product Name: Panitumumab (Vectibix®)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Concentration unit: mg/ml milligram(s)/millili
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically confirmed metastatic colorectal cancer with potentially resectable liver metastases - primary tumor in-situ or resected (in case of resected primary tumor, neoadjuvant short-time radiotherapy is allowed if terminated > 14 days prior to registration) - subjects with wild-type RAS tumor status confirmed by assessment of paraffin embedded tumor tissue from the primary tumor or metastases - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - at least one measurable metastatic lesion in the liver as per RECIST 1.1 guidelines using multislice 3 phase CT - man or woman > 18 years - hematologic function, as follows ( 1.5 x 109/L; leucocyte count > 3.0 x 109g/L; platelet count > 100 x 109/L; hemoglobin > 9 x g/dL - renal function, as follows ( 3 months 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: - prior chemotherapy for the treatment of current metastatic cancer (including biologics) - current extrahepatic metastatic disease - prior chemotherapy and/or resection of any metastases from mCRC <5 years - prior adjuvant or neoadjuvant (chemo-) therapy for the treatment of colorectal cancer = 26 weeks prior to registration - radiotherapy = 14 days prior to registration (patients must have recovered from all radiotherapy-related toxicities) - previous malignancy other than CRC in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix - active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to registration - any investigational agent or therapy < 28 days before registration - clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before registration - known allergy or hypersensitivity to irinotecan, 5-FU, leucovorin or panitumumab - history of severe adverse events to iodinated contrast agents - history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan - known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection - any co-morbid disease or condition that could increase the risk of toxicity - any uncontrolled concurrent illness or history of any medical condition that may interfere with the interpretation of the study results - major surgical procedure (requiring general anaesthesia) < 28 days - patients must have recovered from surgery-related toxicities - subject who is pregnant or breast feeding or planning to become pregnant within 6 months after the end of treatment - woman or man of childbearing potential not consenting to use adequate contraceptive precautions (double barrier contraceptive methods e.g. diaphragm plus condom), or abstinence during the course of the study and 6 months after the last study drug administration - subject unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy and safety of perioperative treatment including panitumumab and FOLFIRI as first line therapy for mCRC in subjects with potentially resectable liver metastases expressing wild-type RAS;Secondary Objective: - evaluation of proportion of patients who respond after 4 cycles of therapy without liver tissue damage - liver resection rate - evaluation of perioperative morbidity and mortality - evaluation of pathological response acc. to tumor regression rate - progression-free survival time (PFS) - overall survival (OS);Primary end point(s): objective response rate (ORR);Timepoint(s) of evaluation of this end point: after neoadjuvant therapy (4 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - evaluation of ORR without liver tissue damage - resection rate - evaluation of perioperative morbidity and mortality - proportion of subjects with a complete pathological response - progression-free survival time (PFS) - overall survival (OS);Timepoint(s) of evaluation of this end point: - ORR: after 4 cycles of therapy - Resection rate: after neoadjuvant chemotherapy - PFS: time from registration date to the date of first observed progression disease (PD) or death (whichever comes first) - OS: time from registration date to the date of death. | — |
Countries
Austria
Contacts
Public ContactTrial Office
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Outcome results
None listed