A LOCAL FEASIBILITY STUDY ON MANGAFODIPIR AS AN ADJUNCT TO FOLFOX6 CHEMOTHERAPY IN PATIENTS OPERATED FOR COLORECTAL CANCER STAGE DUKE C (MANFOL) - MANFO
- Conditions
- 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.
- Registration Number
- EUCTR2007-002905-34-SE
- Lead Sponsor
- PledPharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method