Well differentiated neuroendocrine tumor (G1 and G2) MedDRA version: 14.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Vectibix
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Concentration unit: mg/kg milligram(s)/kilogram
Conce
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histological diagnosis of well-differentiated neuroendocrine tumor (G1 and G2) of gastro-entero-pancreatic district or of unknown primary site. •Disease progression after treatment with somatostatin analogues •Previous treatment with everolimus, sunitinib or bevacizumab is admitted. •One chemotherapy is admitted. •Metastatic or locally advanced disease. •Male or female, age > 18 years. •Absence carcinoid syndrome. •ECOG performance status 0-1. •Expectancy of life > 6 months •Written informed consent •Adequate liver function as shown by: serum bilirubin =1.5 x ULN; ALT and AST 1.5 x 109/L;PLT > 100 x 109/L; Hb > 9 g/dL •Creatinine clearance > 50 ml/min •Magnesium and calcium > lower limit of normal •At least one measurable lesion at CT scan as defined by RECIST •Women of childbearing potential must have had a negative serum or urine pregnancy test within 7 days prior to the administration of the study treatment start, and must use an acceptable form of contraception Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: •Patients with a known hypersensitivity to panitumumab •Histological diagnosis of poorly differentiated neuroendocrine carcinoma (G3) •Histological diagnosis of lung neuroendocrine tumors (typical or atypical carcinoid, small cell lung cancer, large cell neuroendocrine carcinoma) •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 12 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function; uncontrolled diabetes; any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study; non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment, such as severe hypertension that is not controlled with medical management and thyroid abnormalities due to which thyroid function cannot be maintained in the normal range by medication; liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis; fatal or life-threatening autoimmune and ischemic disorders; uncontrolled hyperlipidemia •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. •Patients with serious neurological or psychiatric disorders •Patients with central nervous system (CNS) metastases •Patients who have a history of another primary malignancy with the exception of basal or squamous cell skin cancer, in situ cancer, and any cancer from which the patient has been disease free for 5 years •Immunocompromised patients, including positive HIV test. An HIV test is not required to enter the study •Female patients who are pregnant or breast feeding •Patients of reproductive potential who are not using appropriate contraceptive methods. Appropriate forms of contraception are: IUD, oral or depot contraceptive or the barrier method plus spermicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity and efficacy of panitumumab in metastatic or locally advanced well differentiated neuroendocrine tumor after somatostatine analogues and possible chemotherapy.;Secondary Objective: To evaluate activity (on further parameters: see §2.4), efficacy and tolerability of panitumumab in metastatic or locally advanced well differentiated neuroendocrine tumor after somatostatine analogues and chemotherapy.;Primary end point(s): Activity is defined as Non-progression rate, (RECIST criteria version 1.1), as evaluated at 6 months.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Best objective response (CR + PR according to RECIST criteria version 1.1): complete plus partial responses, as evaluated at 6 months Biochemical response (changes of tumor marker values) Time to progression (TTP) and overall survival (OS), as estimated by the Kaplan-Meier method. Adverse reaction definition and grading according to CTC-AE v.3.0;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactUfficio Assistenza Ricerca Clinica
Gruppo ITMO
Outcome results
None listed