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

Institut Claudius Regaud

Status and phase: Terminated; Phase 2

Conditions: Anemia; Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00210002

03 DIVE 01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)