Overview

Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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 the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Egetis Therapeutics
PledPharma AB
Treatments:
Edetic Acid
Pyridoxal Phosphate
Criteria
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
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 (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