The study subjects will be patients with operated colorectal cancer stage Duke C who are going through standard FOLFOX6 treatment (5-FU, calcium-levofoliate and oxaliplatin). The objective of the study is to investigate whether mangafodipir (Teslascan) can lower the incidence of FOLFOX6-related adverse events and increase quality of life.
Conditions
Interventions
Trade Name: Teslascan
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
PledPharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colorectal cancer stage Duke C. 2) Patient over 18 years. 3) WHO performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the present study is to find out whether pre-treatment with the compound mangafodipir lowers the frequency and/or severity of FOLFOX6-related haematological toxicity and neurosensory toxicity in patients operated for colorectal cancer in stage Duke C.;Secondary Objective: The secondary objective will be to evaluate the frequency of other common adverse events, quality of life during FOLFOX6 regimen and number of patients requiring dose reduction. ;Primary end point(s): The primary end points will be two of the most frequent toxic manifestations of FOLFOX6, namely neutropenia and neurosensory toxicity | — |
Countries
Sweden
Outcome results
None listed