FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study. - Nordic 7.5

Odense University Hospital0 个研究点目标入组 86 人开始时间: 2008年2月27日最近更新: 2013年11月11日

试验速览

暂无简介。

•Histology and staging disease:
•Histological proven adenocarcinoma of the colon or rectum
•At least one measurable metastatic lesion according to RECIST criteria
•If only one metastatic lesion, histology is mandatory
•Mutation level:
•Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR
•General conditions:
•Age >18 and < 75 years
•WHO performance status = 2; life expectancy of more than 3 months
•Adequate haematological function: (Hb = 6.2 µmol/d, ANC = 1.5 x 109/L, platelets = 100 x 109/L)
•Adequate renal and hepatic functions: total bilirubin = 1.5 upper normal limit, creatinine = 1.25 × upper normal limit, ALAT = 3 x upper normal limits, and = 5 x upper normal limits in case of liver metastases
•Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements
•Fertile patients must use adequate contraceptives
•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

•Prior therapy:
•Prior chemotherapy for advanced/metastatic disease
•Adjuvant chemotherapy must have ended > 6 months before inclusion
•Prior treatment with Eloxatin
•Prior treatment with Erbitux or other treatment to EGFR
•Prior or current history:
•Current indication for resection with a curative intent
•Evidence of CNS metastasis
•Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
•Current history of chronic diarrhoea
•Peripheral neuropathy
•Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)
•Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
•Concomitant treatments:
•Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
•Concurrent treatment with any other anti-cancer therapy
•Pregnant or breast feeding women

发起方