Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

This study has been terminated.
Sponsor:
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00210002
First received: September 12, 2005
Last updated: November 13, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Neoplasms
Anemia
Drug: Darbepoetin alfa (Aranesp®)
Drug: Ferric saccharose(Venofer®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Biological response rate for each group.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 55
Study Start Date: November 2003
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00210002

Locations
France
Centre Hospitalier de Castres
Castres, France
Centre Hospitalier de Montauban
Montauban, France
Institut Claudius Regaud
Toulouse, France
Centre Hospitalier Joseph Ducuing
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Roland Dugat, Pr Institut Claudius Regaud
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210002     History of Changes
Other Study ID Numbers: 03 DIVE 01
Study First Received: September 12, 2005
Last Updated: November 13, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Neoplasms
Solid
Anemia
darbepoetin alfa
ferric saccharose
Venofer®
Aranesp®

Additional relevant MeSH terms:
Neoplasms
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014