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SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

Inclusion Criteria:

- 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

- 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

- 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

- 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 Criteria:

- 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

- 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

- Pregnancy and breast-feeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease control

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Emmannuelle SAMALIN-SCALZI, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle-Paul Lamarque


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

February 2009

Completion Date:

February 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms