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Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
This study has been terminated.
Study NCT00210002   Information provided by Institut Claudius Regaud
First Received: September 12, 2005   Last Updated: November 13, 2006   History of Changes

September 12, 2005
November 13, 2006
November 2003
 
Biological response rate for each group.
Same as current
Complete list of historical versions of study NCT00210002 on ClinicalTrials.gov Archive Site
  • To determine tolerance for ferric saccharose (Venofer®)
  • To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
  • To determine percentage of hemoglobin rate's correction
  • To determine biological parameters's evolution
Same as current
 
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

 
Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Neoplasms
  • Anemia
  • Drug: Darbepoetin alfa (Aranesp®)
  • Drug: Ferric saccharose(Venofer®)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
55
April 2006
 

Inclusion Criteria:

  • Age ≥ 18 years
  • Well-informed written consent, signed by the patient
  • Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
  • Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9<Hb<12 g/dl; Women: 9<Hb<11 g/dl.
  • Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study
  • Patients with life expectancy higher than three months
  • Patient with general conditions compatible with the study's follow-up

Exclusion Criteria:

  • Contra-indication for Venofer
  • Anemia which can have curative treatment
  • Bloody transfusion during the previous four weeks
  • Documented or suspected medullary invasion
  • Uncontrolled arterial hypertension
  • Acute bacterial infection
  • Transferrin saturation's coefficient
  • Pregnancy
  • Ferric salts oral treatment interrupted since less than one week
  • Patient with bad french language's comprehension
  • Patient with a major psychiatric pathology
  • Patient under guardianship, trusteeship or justice safeguard
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00210002
 
03 DIVE 01
Institut Claudius Regaud
 
Principal Investigator: Roland Dugat, Pr Institut Claudius Regaud
Institut Claudius Regaud
November 2006

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