A LOCAL FEASIBILITY STUDY ON MANGAFODIPIR AS AN ADJUNCT TO FOLFOX6 CHEMOTHERAPY IN PATIENTS OPERATED FOR COLORECTAL CANCER STAGE DUKE C (MANFOL) - MANFO

PledPharma AB0 个研究点开始时间: 2007年10月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1) Histologically proven colorectal cancer stage Duke C.
•2) Patient over 18 years.
•3) WHO performance status <1.
•4) Adequate haematological function (Hb = 100 g/L, ANC = 2.0 x 109/L, platelets = 150 x 109/L)
•5) Adequate renal and hepatic functions: serum creatinine and total bilirubin = 1.25 times upper normal limits (ASAT and ALAT = 3 times upper normal limits)
•6)Clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy
•7)Use of adequate contraception
•8)Written informed consent given (Appendix A)
•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

•1) Other tumour types than colorectal adenocarcinomas
•2) Current severe neutropenia, leucopenia or thrombocytopenia
•3) Severely reduced liver or renal function
•4) Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn’s disease or ulcerative colitis
•5) Current chronic diarrhoea
•6) Contraindication for corticosteroid administration
•7) History of prior serious allergic or pseudo-allergic reaction
•8) Any other serious illness or medical condition
•9) Symptomatic peripheral neuropathy = grade 2 (Sanofi-NCI criteria)
•10) Received mangafodipir = 5 weeks before planned start of chemotherapy
•11) Received any of the FOLFOX drugs = 5 weeks planned start of chemotherapy
•12) Any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study
•13) Pregnant or nursing females
•14) Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
•15)Pheochromocytoma

发起方

PledPharma AB