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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00210002
• Other study ID #: 03 DIVE 01
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 13, 2006
• Start date: November 2003
• Est. completion date: April 2006

Study information

• Verified date: November 2006
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

Drug:
• Darbepoetin alfa (Aranesp®)

• Ferric saccharose(Venofer®)

Locations

Country	Name	City	State
France	Centre Hospitalier de Castres	Castres
France	Centre Hospitalier de Montauban	Montauban
France	Centre Hospitalier Joseph Ducuing	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological response rate for each group.
Secondary	To determine tolerance for ferric saccharose (Venofer®)
Secondary	To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
Secondary	To determine percentage of hemoglobin rate's correction
Secondary	To determine biological parameters's evolution