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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 13, 2006

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Biological response rate for each group.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00210002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Neoplasms
Anemia

Intervention ^ICMJE

Drug: Darbepoetin alfa (Aranesp®)
Drug: Ferric saccharose(Venofer®)

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00210002

Responsible Party

Study ID Numbers ^ICMJE

03 DIVE 01

Study Sponsor ^ICMJE

Institut Claudius Regaud

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roland Dugat, Pr

Institut Claudius Regaud

Information Provided By

Institut Claudius Regaud

Verification Date

November 2006

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