Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques
NCT01704703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2017-08-01
Summary
Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques.
Conditions
- Stage IV Colorectal Cancer
Interventions
- DRUG
-
panitumumab
Panitumumab 6,0 mg/kg day 1 i.v. 60 min
- DRUG
-
Irinotecan 180 mg/m2 day 1 i.v. 30-90 min Folinic acid 400 mg/ m2 day 1 i.v. 120 min 5-FU 400 mg/ m2 day 1 Bolus 5-FU 2.400 mg/ m2 day 1 i.v. 46 hours
Sponsors & Collaborators
-
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
lead OTHER
Principal Investigators
-
Ramón Salazar, MD, PhD · Institut Català d´Oncologia (ICO) L'Hospitalet
-
Gabriel Capella · Institut Català d´Oncologia (ICO) L'Hospitalet
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- Spain
Study Locations
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