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

This study has been terminated.

First Received: September 12, 2005 Last Updated: November 13, 2006 History of Changes

Sponsor:	Institut Claudius Regaud
Information provided by:	Institut Claudius Regaud
ClinicalTrials.gov Identifier:	NCT00210002

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Dietary Supplements

Drug Information available for: Sucrose Darbepoetin alfa Ferric oxide, saccharated

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210002

Locations

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

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

Principal Investigator:

Roland Dugat, Pr

Institut Claudius Regaud

More Information

No publications provided

Study ID Numbers:	03 DIVE 01
Study First Received:	September 12, 2005
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00210002 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Claudius Regaud:

Neoplasms
Solid
Anemia
darbepoetin alfa

ferric saccharose
Venofer®
Aranesp®

Additional relevant MeSH terms:

Neoplasms
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009