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A Local Feasibility Study on Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Patients Operated Upon Colon Cancer Stage Dukes' C

Phase 2
18 Years
Not Enrolling
Chemotherapy, Colon Cancer

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Trial Information

A Local Feasibility Study on Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Patients Operated Upon Colon Cancer Stage Dukes' C

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 Institute. Preclinical research has shown that mangafodipir protects normal
tissues without loss of anti-tumour activity during chemotherapy. Other advantages are that
mangafodipir is already approved for use in patients as a contrast agent for magnetic
resonance imaging (MRI) of liver, and that the experience for more than a decade reveals
high safety with mainly minor and tolerable side-effects.

The present study will include 14 patients who will be followed throughout 3 treatment
cycles. Each cycle will be preceded by infusion of mangafodipir or placebo in two groups,
each consisting of 7 patients. The primary endpoints will be the most frequent manifestation
of FOLFOX6, namely neutropenia and neurosensory toxicity. The secondary endpoints will be
the frequency and severity of other FOLFOX6-related adverse events and quality of life.

Inclusion Criteria:

1. Histologically proven colon cancer stage Dukes' 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

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 (males with reproductive potential)

8. Written informed consent given

Exclusion Criteria:

1. Other tumour types than colon 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

10. Received mangafodipir ≤ 5 weeks before planned start of chemotherapy

11. Received any of the FOLFOX drugs ≤ 5 weeks before planned start of chemotherapy

12. Any plans of administered other anti-cancer therapy (including radiotherapy)
concurrent with this study

13. Fertile females

14. Males with reproductive potential not implementing adequate contraception measures

15. Phaeochromocytoma

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Before and after completion of one, two and/or three FOLFOX6-cycles

Safety Issue:


Principal Investigator

Ursula Falkmer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Länssjukhuset Ryhov


Sweden: Medical Products Agency

Study ID:

PP 01-07



Start Date:

June 2008

Completion Date:

April 2010

Related Keywords:

  • Chemotherapy
  • Colon Cancer
  • Colonic Neoplasms