Status:
COMPLETED
Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C
Lead Sponsor:
Egetis Therapeutics
Conditions:
Chemotherapy
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy according to t...
Detailed Description
Mangafodipir, manganese (Mn) dipyridoxyl diphosphate, is a catalytic antioxidant and iron chelator recently (2006) suggested for cancer treatment in an Editorial in Journal of the National Cancer Inst...
Eligibility Criteria
Inclusion
- Histologically proven colon cancer stage Dukes' C.
- Patient over 18 years.
- WHO performance status \<1.
- Adequate haematological function (Hb ≥ 100 g/L, ANC ≥ 2.0 x 109/L, platelets ≥ 150 x 109/L)
- Adequate renal and hepatic functions: serum creatinine and total bilirubin ≤ 1.25 times upper normal limits (ASAT and ALAT ≤ 3 times upper normal limits)
- Clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy
- Use of adequate contraception (males with reproductive potential)
- Written informed consent given
Exclusion
- Other tumour types than colon adenocarcinomas
- Current severe neutropenia, leucopenia or thrombocytopenia
- Severely reduced liver or renal function
- Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn's disease or ulcerative colitis
- Current chronic diarrhoea
- Contraindication for corticosteroid administration
- History of prior serious allergic or pseudo-allergic reaction
- Any other serious illness or medical condition
- Symptomatic peripheral neuropathy ≥ grade 2
- Received mangafodipir ≤ 5 weeks before planned start of chemotherapy
- Received any of the FOLFOX drugs ≤ 5 weeks before planned start of chemotherapy
- Any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study
- Fertile females
- Males with reproductive potential not implementing adequate contraception measures
- Phaeochromocytoma
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00671996
Start Date
June 1 2008
End Date
April 1 2010
Last Update
May 4 2010
Active Locations (1)
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1
Onkologkliniken, Länssjukhuset Ryhov
Jönköping, Sweden, SE-551 85