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

This study has been completed.
Sponsor:
Information provided by:
PledPharma AB
ClinicalTrials.gov Identifier:
NCT00671996
First received: May 4, 2008
Last updated: May 3, 2010
Last verified: May 2010

May 4, 2008
May 3, 2010
June 2008
April 2010   (final data collection date for primary outcome measure)
Neutropenia [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00671996 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C
A Local Feasibility Study on Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Patients Operated Upon Colon Cancer Stage Dukes' C

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Chemotherapy
  • Colon Cancer
  • Drug: Mangafodipir

    Treatment will be undertaken with a ready-to-use investigative drug formulation identical to what is in diagnostic use as a contrast medium for MRI.

    Formulation content: MnDPDP 10 mmol/ml

    Administered dose per cycle: 2 μmol/kg b.w. Administration form: Ready-to-use formulation (solution). Mangafodipir or placebo (0.2 ml/kg b.w.) will be administered as an i.v. infusion over 5 min about 30 min prior to start of chemotherapy.

    Other Name: Teslascan; ACT code V08CAE05
  • Drug: Placebo treatment (0.9% NaCl)
    Intravenous infusion, 2 micromol/kg, pretreatment 30 minutes before the start of FOLFOX treatment (during the first three FOLFOX treatments)
  • Active Comparator: A
    Mangafodipir treatment
    Intervention: Drug: Mangafodipir
  • Placebo Comparator: B
    Intervention: Drug: Placebo treatment (0.9% NaCl)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00671996
PP 01-07
No
Jan Olof G. Karlsson, PledPharma AB, Grev Turegatan 7, SE-11446 Stockholm
PledPharma AB
Not Provided
Principal Investigator: Ursula Falkmer, MD, PhD Länssjukhuset Ryhov
PledPharma AB
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP