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

Condition(s) targeted: Neoplasms; Anemia

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

Phase: Phase 2

Status: Terminated

Sponsored by: Institut Claudius Regaud

Official(s) and/or principal investigator(s):
Roland Dugat, Pr, Principal Investigator, Affiliation: Institut Claudius Regaud

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.

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

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

Primary outcome: Biological response rate for each group.

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 - 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

Institut Claudius Regaud, toulouse, France

Centre Hospitalier de Castres, Castres, France

Centre Hospitalier Joseph Ducuing, Toulouse, France

Centre Hospitalier de Montauban, Montauban, France

Starting date: November 2003
Ending date: April 2006
Last updated: November 13, 2006