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

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

MedlinePlus related topics:

Anemia Cancer

ChemIDplus related topics:

Darbepoetin alfa Sucrose Ferric oxide, saccharated

U.S. FDA Resources

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.

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

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

Keywords provided by Institut Claudius Regaud:

Neoplasms

Solid

Anemia

darbepoetin alfa

ferric saccharose

Venofer®

Aranesp®

Study placed in the following topic categories:

Ferric oxide, saccharated

Hematologic Diseases

Darbepoetin alfa

Anemia

Iron

Additional relevant MeSH terms:

Neoplasms

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

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