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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Terminated

CT.gov ID

NCT00210002

Collaborator

(none)

Enrollment

Locations

Duration (Months)

13.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Anemia	Drug: Darbepoetin alfa (Aranesp®) Drug: Ferric saccharose(Venofer®)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2003

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Biological response rate for each group. []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Centre Hospitalier de Castres	Castres	France
2	Centre Hospitalier de Montauban	Montauban	France
3	Centre Hospitalier Joseph Ducuing	Toulouse	France
4	Institut Claudius Regaud	Toulouse	France