Patients with metastatic colorectal cancer confined to the liver who underwent R0/1 resection of liver metastases MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Vectibix
Product Name: Panitumumab
Product Code: Panitumumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Current Spo
Sponsors
Klinikum der Universität München-Großhadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has provided written informed consent. 2. R0/1-resection of liver metastasis, at least four weeks but not longer than 8 weeks ago (submission of the pathologist´s report to exclude R2 resection status is mandatory for randomisation) 3. Histologically confirmed diagnosis of metastatic colorectal cancer confined to the liver 4. RAS wild-type of the tumor, tested in: • KRAS exon 2 (codons 12/13) • KRAS exon 3 (codons 59/61) • KRAS exon 4 (codons 117/146) • NRAS exon 2 (codons 12/13) • NRAS exon 3 (codons 59/61) • NRAS exon 4 (codons 117/146) 5. Age 18 years or older 6. ECOG performance status 0-1 7. Females with child-bearing potential must use adequate contraceptive measures 8. Exclusion of pregnancy 9. Relevant toxicities of previous treatments must have subsided 10. Magnesium = lower limit of normal; Calcium = lower limit of normal 11. Normal cardiac function demonstrated by ECG and echocardiogram (LVEF = 55%) • No symptomatic congestive heart failure • No unstable angina pectoris • No cardiac arrhythmia 12. Adequate organ function as defined by Table 1: Table 1: Adequate Hepatic and Renal Function Values SYSTEM LABORATORY VALUES Hematologic ANC (absolute neutrophil count) = 1.5 G/L Leucocytes > 3.0 G/L Hemoglobin = 9 g/dL Platelets = 100 G/L Hepatic Albumin = 2.5 g/dL Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known manifestations of metastatic disease 2. Progression during preoperative treatment 3. RAS mutation of the tumor 4. Contraindication against therapy with 5-Fluorouracil/ folinic acid or oxaliplatin 5. Known intolerability of panitumumab 6. Known DPD deficiency 7. Polyneuropathy > grade 1 (NCI-CTCv4) which precludes the use of oxaliplatin 8. Evidence of ascites or cirrhosis 9. Patient is pregnant or lactating or planning to become pregnant within 6 months after end of treatment 10. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment 11. Has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrolment, or there is an anticipated need for major surgical procedure during the course of the study. This excludes minor surgical procedures like implantation of intravenous portsystems (7 days prior enrolment) or central venous catheters (2 days prior enrolment). 12. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrolment/randomisation 13. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan 14. Has a concurrent disease or condition that would make the subject inappropriate for study participation or would interfere with the subject’s safety. 15. Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 16. Requires concurrent cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) while on study. 17. Requires concurrent treatment with an investigational agent, participation in another clinical trial, or any specifically prohibited medication while on study. 18. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to 5-Fluorouracil, folinic acid, oxaliplatin, or panitumumab. 19. Other active malignancy 20. Known alcohol abuse or drug addiction 21. Incapability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in RAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody.;Secondary Objective: The study aims to investigate the tolerability of panitumumab-based therapy in the postoperative setting. In addition, predictors of treatment efficacy shall be identified by an evaluation of the molecular pathology of the disease. ;Primary end point(s): • Progression-free survival (PFS) rate at 2 years after randomisation ;Timepoint(s) of evaluation of this end point: 2 years after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment tolerability and side effects • Overall survival ;Timepoint(s) of evaluation of this end point: • after end of chemotherapy (3 month) in both arms • after end of maintainance (6 month) in experimental arm only | — |
Countries
Austria, Germany
Contacts
Public ContactStudy office
Klinikum der Universität München-Großhadern
Outcome results
None listed