Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
This study has been terminated.
Sponsor:
Institut Claudius Regaud
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00210002
First received: September 12, 2005
Last updated: November 13, 2006
Last verified: November 2006
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms Anemia |
Drug: Darbepoetin alfa (Aranesp®) Drug: Ferric saccharose(Venofer®) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced. |
Resource links provided by NLM:
Further study details as provided by Institut Claudius Regaud:
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
| Estimated Enrollment: | 55 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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<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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210002
Locations
| France | |
| Centre Hospitalier de Castres | |
| Castres, France | |
| Centre Hospitalier de Montauban | |
| Montauban, France | |
| Institut Claudius Regaud | |
| Toulouse, France | |
| Centre Hospitalier Joseph Ducuing | |
| Toulouse, France | |
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
| Principal Investigator: | Roland Dugat, Pr | Institut Claudius Regaud |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00210002 History of Changes |
| Other Study ID Numbers: | 03 DIVE 01 |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 13, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Claudius Regaud:
|
Neoplasms Solid Anemia darbepoetin alfa |
ferric saccharose Venofer® Aranesp® |
Additional relevant MeSH terms:
|
Anemia Neoplasms Hematologic Diseases Darbepoetin alfa |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013