Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation (NCT00989469) | Clinical Trial Compass
CompletedPhase 1/2
Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation
France64 participantsStarted 2009-02
Plain-language 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 mutation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 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 inc…
What they're measuring
1
disease control
Timeframe: 6 months
Trial details
NCT IDNCT00989469
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle