Adenocarcinoma of the stomach or the gastroesophageal junction MedDRA version: 14.1 Level: LLT Classification code 10017768 Term: Gastric cancer stage IV without metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Cla
Conditions
Interventions
Trade Name: Vectibix
Product Name: Panitumumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Panitumumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either - distant metastases (TX NX M1) or - locally advanced disease (T3/4 N0 M0) or - stage II / III (> T1 N2 / T2a/b N1) • No preceding cytotoxic or targeted therapy (adjuvant treatment allowed if finished = 6 months before inclusion) • Patients with confirmed KRAS wildtype • At least one unidimensional, measurable tumour parameter according to RECIST • Age = 18 years • ECOG = 2 • Adequate haematological, hepatic, renal and metabolic function parameters: Leukocytes > 3000/mm³, ANC = 1500/mm3, platelets = 100,000/mm3, Hb > 9g/dl (may be transfused or treated with erythropoietin to maintain or exceed this level) Serum creatinine = 1.5 x upper limit of normal Bilirubin = upper limit of normal, ASAT and ALAT = 2.5 x upper limit of normal. AP = 2,5 upper limit of normal Magnesium = lower limit of normal; calcium = lower limit of normal • Written and signed patient consent form 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, docetaxel, panitumumab • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment. • History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. • Known brain metastases • Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix • Other severe internal disease (e.g. insufficiently treated arterial hypertension, other uncontrolled severe disease) • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. • 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). • Peripheral polyneuropathy > NCI Grade I • Chronic inflammatory bowel disease • On-treatment participation in a clinical study in the period 30 days prior to inclusion • Known her2 neu overexpression defined as either Her2 3+ in immunohistochemistry or 2+ in immunohistochemistry and FISH positivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: objective remission rate ;Secondary Objective: •Determination of progression-free survival •Time to progression •Overall survival •Adverse events / toxicity •Evaluation of prognostic factors (EGFR signaling, PTEN loss, pharmacogenetics, molecular biology) ;Primary end point(s): objective remission rate | — |
Countries
Germany
Outcome results
None listed