NeoplasmsPhase 2NCT00210002
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
A Phase 2 study testing Darbepoetin alfa (Aranesp®) and Ferric saccharose(Venofer®) in people with Neoplasms and Anemia, run by Institut Claudius Regaud at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Darbepoetin alfa (Aranesp®) and Ferric saccharose(Venofer®)
- How many people
- 55 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2003to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier de Castres
Castres
Centre Hospitalier de Montauban
Montauban
Centre Hospitalier Joseph Ducuing
Toulouse
Institut Claudius Regaud
Toulouse
About this study
Official title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
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.
- Being tested
- Darbepoetin alfa (Aranesp®), Ferric saccharose(Venofer®)
- Keywords
- Neoplasms, Solid, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfa (Aranesp®)Drug
Ferric saccharose(Venofer®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological response rate for each group.
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Investigators
- Roland Dugat, Pr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210002
- Sponsor's protocol ID
- 03 DIVE 01
- Status last verified
- Nov 2006
- First submitted
- 12 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
- ClinicalTrials.gov ID
- NCT00210002
- Acronym / sponsor ID
- 03 DIVE 01
- Keywords
- Neoplasms, Solid, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 55 participants
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Apr 2006
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin alfa (Aranesp®) | Drug | – |
| Ferric saccharose(Venofer®) | Drug | – |
Primary outcome
Biological response rate for each group.
4 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Dugat, Pr principal investigator
Institut Claudius Regaud
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin alfa (Aranesp®) and Ferric saccharose(Venofer®) in people with Neoplasms and Anemia, run by Institut Claudius Regaud at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological response rate for each group.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2006.