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

November 13, 2006 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Castres, France
        • Centre Hospitalier de Castres
      • Montauban, France
        • Centre Hospitalier de Montauban
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • Centre Hospitalier Joseph Ducuing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biological response rate for each group.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Roland Dugat, Pr, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2006

Last Update Submitted That Met QC Criteria

November 13, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03 DIVE 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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