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

Phase 2

Terminated

• Conditions: Neoplasms; Anemia

• Registration Number: NCT00210002
• Lead Sponsor: Institut Claudius Regaud

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

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-04
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-13
• Last Update Posted: 2006-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biological response rate for each group.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Centre Hospitalier de Montauban; 🇫🇷 Montauban, France

Centre Hospitalier Joseph Ducuing; 🇫🇷 Toulouse, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Hospitalier de Castres; 🇫🇷 Castres, France