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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by PledPharma AB:

Primary Outcome Measures:
  • Neutropenia [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Before and after completion of one, two and/or three FOLFOX6-cycles ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671996

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

Publications:
Responsible Party: Jan Olof G. Karlsson, PledPharma AB, Grev Turegatan 7, SE-11446 Stockholm
ClinicalTrials.gov Identifier: NCT00671996     History of Changes
Other Study ID Numbers: PP 01-07
Study First Received: May 4, 2008
Last Updated: May 3, 2010
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Edetic Acid
Pyridoxal Phosphate
N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 30, 2014