EUCTR2008-004923-48-DKActive, not recruitingNot Applicable
En fase II undersøgelse af Irinotecan og Panitumumab som 3. linje behandling til patienter med metastaserende colorectal cancer uden KRAS mutationer.
Vejle Sygehus0 sitesStarted: August 26, 2008Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Histologisk verificeret adenocarcinom i colon eller rectum med metastatisk spredning.
- •Resistens for 5-FU, Oxaliplatin og Irinotecan.
- •Alder > 18 år.
- •Målbar sygdom i henhold til RECIST kriterierne.
- •Hæmatologi: Neutrofilocytter > 1.5 x 109/l, leukocytter > 3.0 x 109/l, thrombocytter > 100 og bilirubin < 3 x øvre normal grænse.
- •Fertile kvinder skal have negativ graviditetstest og anvende sikker antikonception under og 3 måneder efter behandlingen.
- •Accept af, at blod og vævsprøver gemmes til senere undersøgelse af biomarkører.
- •Skriftligt og mundtligt informeret samtykke.
- •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
- •Anden malign lidelse inden for de sidste 5 år, fraset non-melanom hudcancer og carcinoma in situ cervicis uteri.
- •Kemoterapi, stråleterapi eller immunterapi inden for 4 uger.
- •CNS metastaser.
- •Anden eksperimentel behandling.
- •Alvorlige medicinske lidelser.
- •Gravide eller ammende kvinder.
- •Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
- •Patienter med interstitiel pneumonitis eller pulmonær fibrose.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Estudio de fase II con una combinación de Irinotecán, Capecitabina (Xeloda®) y Bevacizumab (Avastin®) en cáncer colorrectal metastático no pretratado - AVAXIRICáncer colorrectal metastásico no pretratadoMedDRA version: 9.1Level: LLTClassification code 10010029Term: Colorectal cancer NOSEUCTR2008-004688-20-ESGrupo de Tratamiento de los Tumores Digestivos (TTD)
Completed
Phase 2
Phase II CPT-11, LV and 5FU in Gastric CancerCancer - StomachGastric CancerACTRN12605000706673Site - Investigator Initiated . AGITG sponsored trial, conducted through NHMRC CTC80
Active, not recruiting
Not Applicable
Estudio de fase II de la combinación de panitumumab con paclitaxel como tratamiento de primera línea de sujetos con cáncer de cabeza y cuello recurrente o metastásico - VECTITAXEUCTR2010-018898-37-ESGrupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC)
Completed
Phase 1
A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)advanced/recurrent colorectal cancerJPRN-UMIN000001617CPT-11/TS-1 study group30
Completed
Phase 2
phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patientsmetastatic colorectal cancerJPRN-UMIN000005180Yokohama city university37