Status:
COMPLETED
Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
Bayer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutat...
Eligibility Criteria
Inclusion
- Age \> 18
- Written informed consent
- Histologically proven adenocarcinoma of the colon or rectum asymptomatic primary tumour or surgically removed mCRC patients with previously unresectable metastatic disease
- Patient with at least one tumoral lesion: measurable in a unidimensional way with a spiral scanner according to RECIST, no previous irradiation in this area
- Disease progression after irinotecan-based chemotherapy
- Disease progression after one or more previous lines of chemotherapy received in metastatic situation
- WHO \<= 2
- Patient having a mutated KRAS on 12 or 13 codons on the primary tumour or a metastasis
- Adequate liver function : Bilirubin ≤ 1,5 x UNL, ASAT ou ALAT ≤ 2,5 x UNL (or \< 5 x UNL for subjects having a hepatic insufficiency in connection with hepatic metastases)
- Polynuclear neutrophils ≥ 1 500/mm3
- Haemoglobin \> 10g/dl
- Platelets ≥ 100 000/mm3
- Amylase and lipase \< 1,5 x UNL
- Serum Creatinin \< 1,5 x UNL
- Adapted contraceptive measures during treatment and continued at least three months after end of the treatment
- Life expectancy \> 3 months
- Affiliated to or benefiting from health insurance
Exclusion
- Gilbert's disease
- Brain metastases or carcinomatous symptomatic meningitis
- Exclusive bone metastasis
- Previous cancers not considered as cured in the 5 years before inclusion (except for baso-cellular skin carcinoma) Surgery (except diagnostic biopsy) or radiotherapy within 4 weeks before inclusion
- Disorders of the cardiac rhythm requiring an anti-asynchronous treatment (except beta blockers or digoxine within the framework of a chronic auricular fibrillation), unstable coronaropathy or myocardial infarction \< 6 months, congestive cardiac failure \> Rank II NYHA (Grade 2), uncontrolled arterial hypertension
- Previous epilepsy crises requiring long term antiepileptic treatment Previous organ transplant requiring immunosuppressor treatment Severe bacterial or fungus infection (\> Grade 2 NCI CTC version 3) Known HIV Infection
- Long term treatment by known inductors of the CYP 3A4 like Rifampicin, Millepertuis (hypericum perforatum), Phenytoin, Carbamazepin, Phenobarbital, Dexamethasone et Ketonazole
- Known allergy to one of the therapeutic agents
- Reasons (psychological, family, social or geographical) that could compromise the participation of the patient in the study
- Intestinal malabsorption or gastro-intestinal surgery being able to affect Sorafenib absorption. Occlusive or sub-occlusive syndrome.
- Dysphagic patient or patient not being able to take treatment by orally inflammatory
- Chronic digestive disease involving chronic diarrhoea (NCI N+Bethesda \>= 1.2g)
- Participation in another clinical trial within 30 days before the start of this study
- Other concomitant experimental drugs or other concomitant anticancer agents (except Irinotecan and Sorafenib)
- Medical or psychological state that in the opinion of the investigator will not allow the patient to terminate the study or to understand and sign the informed consent form
- Pregnancy and breast-feeding
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00989469
Start Date
February 1 2009
End Date
February 1 2012
Last Update
June 23 2021
Active Locations (5)
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1
Centre Oscar Lambret
Lille, France
2
Hopital Saint Eloi
Montpellier, France
3
Centre Rene Gauducheau
Nantes, France
4
Centre Antoine Lacassagne
Nice, France