Rectal cancer stage 2-3 includes neoadjuvant chemo radiation, followed by resection, followed by adjuvant chemotherapy. MedDRA version: 12.1 Level: LLT Classification code 10010033 Term: Colorectal cancer stage II MedDRA version: 12.1 Level: LLT Classification code 10010034 Term: Colorectal cancer stage III
Conditions
Interventions
Trade Name: VECTIBIX
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Panitumumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
Anticancer Informing "Me Gnosi Nika"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following must be met • Written Informed consent • Adult patients with resected rectal cancer, stage 2 and 3 • Wild-type kRAS tumor status • Age > 18 • Adequate PS 3,000/mm3 • Hemoglobin > 9mg/dL Hepatic Function: • Total bilirubin = 1.5 time the upper normal limit (UNL) • AST (SGOT) = 2.5xUNL • ALT (SGPT) = 2.5xUNL • Renal Function • Creatinine clearance =50 mL/min • Metabolic Function - Magnesium = lower limit of normal. - Calcium = lower limit of normal. 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: • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment/randomization • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. • 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. • Any significant co-morbidity precluding administration of adjuvant chemotherapy • Patients who have previously received Vectibix or Cetuximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility and preliminary efficacy of adding standard dose panitumumab to standard dose adjuvant FOLFOX4 chemotherapy in patients with resected rectal cancer;Secondary Objective: Incidence of all grades, panitumumab-related toxicity Incidence of grade 3 events Relative dose intensity achieved (vectibix, oxaliplatin and 5FU) Disease-free survival (DFS) at 2 years, starting from the first study drug administration ;Primary end point(s): Incidence of unacceptable toxicity (defined as grade 4 adverse event or any toxicity leading to discontinuation of therapy) of the combination of FOLFOX4-panitumumab, as per NCI-CTC guidelines, version 3 | — |
Countries
Greece
Outcome results
None listed