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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671996
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 4, 2010
Information provided by:
PledPharma AB

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 the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.

Condition or disease Intervention/treatment Phase
Chemotherapy Colon Cancer Drug: Mangafodipir Drug: Placebo treatment (0.9% NaCl) Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Local Feasibility Study on Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Patients Operated Upon Colon Cancer Stage Dukes' C
Study Start Date : June 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Active Comparator: A
Mangafodipir treatment
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
Placebo Comparator: B 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)

Primary Outcome Measures :
  1. Neutropenia [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671996

Onkologkliniken, Länssjukhuset Ryhov
Jönköping, Sweden, SE-551 85
Sponsors and Collaborators
PledPharma AB
Principal Investigator: Ursula Falkmer, MD, PhD Länssjukhuset Ryhov

Responsible Party: Jan Olof G. Karlsson, PledPharma AB, Grev Turegatan 7, SE-11446 Stockholm Identifier: NCT00671996     History of Changes
Other Study ID Numbers: PP 01-07
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Edetic Acid
Pyridoxal Phosphate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs