metastatic colorectal cancer MedDRA version: 13.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VECTIBIX*INFUS 1FL 10ML 20MG/M
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PANITUMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conce
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Pathologic diagnosis of metastatic colorectal adenocarcinoma ? A wild-type tumor KRAS gene determined from tumor DNA ? Failure from previous treatment with fluoropirimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab. ? Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment. ? Age 18 years ? ECOG Performance Status 0-2 ? Neutrophils ? 1,5 x 109/L, platelets ? 100 x 109/L, and hemoglobin ? 9 g/dL ? Bilirubin level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Symptomatic brain metastasis ? Interstitial pneumonitis or pulmonary fibrosis ? Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer) ? Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks ? Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess if panitumumab is active enough to warrant further comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.;Secondary Objective: To describe: obiective responses, progression free survival, overall survival and toxicity ? To perform exploratory analysis of tumour-tissue for biological or genomic determinants of outcome, including N-ras, BRAF and PI3K mutational status, EGFR and PTEN expression status;Primary end point(s): Primary end-point is the rate of patients alive and non progressed at 2 months. | — |
Countries
Italy
Outcome results
None listed