histologically confirmed Metastatic colorectal adenocarcinoma MedDRA version: 9.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Interventions
Trade Name: Vectibix
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: panitumumab
Other descriptive name: panitumumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed metastatic adenocarcinoma of the colon or rectum by the Investigator. • Wild Type KRAS (no mutation) by allelic discrimination on tumor DNA • Prior chemotherapy regimens for mCRC with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± Bevacizumab • At least 1 uni-dimensionally measurable lesion of at least 10 mm per modified-RECIST criteria (All sites must be evaluated = 28 days prior to the enrolment). • Prior radiotherapy is acceptable. It must be at least 14 days since administration of radiation therapy and all signs of early toxicity must have abated. • World Health Organisation (WHO) performance status of 0, 1 or 2 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: • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia (treated or not) • Presence of KRAS mutation by allelic discrimination on tumor DNA • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (cetuximab) because of an infusion reaction may participate in this clinical trial. • Prior radiotherapy within 14 days since administration of radiation therapy to enrollment. All signs of early toxicity must have abated. • Metastases of the central nervous system • Pregnancy ; breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan for Patients with Advanced Metastatic Colorectal Cancer without KRAS mutation (Wild type) in third line chemotherapy = Patients pretreated with oxaliplatin and Fluorpyrimidines (5FU/FA or capecitabine) ± bevacizumab and Irinotecan alone or in association with Fluorpyrimidines (5FU/FA or capecitabine) ± bevacizumab;Secondary Objective: To assess the combination therapy of panitumumab plus irinotecan on other efficacy measures in this population : disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), time to progression (TTP), time to treatment failure (TTF), duration of stable disease (DoSD). To assess in this population the efficacy and safety of the treatment strategy of combination therapy of panitumumab plus irinotecan, followed by panitumumab alone for subjects who discontinue irinotecan as third line therapy due to toxicity in subjects with previously treated metastatic colorectal cancer. ;Primary end point(s): • Objective response rate (ORR) during the combination therapy phase: Incidence of either a radiologically confirmed CR or PR while in the combination treatment phase; subjects prematurely discontinuing without a post baseline tumour response assessment, or subjects who respond during the optional panitumumab monotherapy phase, or subjects with an observed CR or PR in the combination phase that is not confirmed (in either the combination or monotherapy phases) will be considered non-responders. | — |
Countries
France
Outcome results
None listed