SarcomaNCT00283621
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
A study testing Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim) and Adriamycin in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim) and Adriamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2003to 12 Apr 2006
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated
- Must be between 18-65 years of age
- Women of childbearing potential should use effective contraceptive measures
- Adequate hematologic, renal, and hepatic functions
- Karnofsky performance status above or equal to 80
Who cannot join
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication
- Patients with metastatic disease to CNS
- Patients with significant cardiac abnormalities
- History of seizure disorder in the past 5 years
- Patient has received any packed red blood cell transfusion within 2 weeks before study entry
Show all 10Show fewer
- Prior surgery or radiation therapy within 2 weeks of study entry
- History of prior chemotherapy for sarcomas
- Iron deficiency
- Hypersensitivity to E.coli derived products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
Read the detailed description
The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.
- Conditions
- Sarcoma
- Being tested
- Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim), Adriamycin, Ifosfamide
- Keywords
- Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF, Ifosfamide
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aranesp (darbepoetin alfa)Drug
Neulasta (pegfilgrastim)Drug
AdriamycinDrug
Also called Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF
IfosfamideDrug
Also called Ifex
| Study group | Role | What they receive |
|---|---|---|
| Growth Factors + Adriamycin/Ifosfamide | Experimental | Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) Receives: Drug: Aranesp (darbepoetin alfa); Drug: Neulasta (pegfilgrastim); Drug: Adriamycin; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBC diff/platelet counts
Measured: Monitored at least twice a week and daily during severe myelosuppression.
Iron Stores
Measured: Blood drawn at baseline during cycle 3 and at the end of study.
Peripheral blood and bone marrows
Measured: Performed at baseline and post treatment.
Secondary outcomes (1)
Neurocognitive functions and Symptom burden assessment
Measured: Assessed at baseline, after 3 cycles of treatment and at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study start2 Jun 2003
- Primary completion12 Apr 2006
- Study completion12 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, M.D., Principal investigator, UT MDAnderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283621
- Sponsor's protocol ID
- ID02-326
- Status last verified
- Nov 2018
- First submitted
- 27 Jan 2006
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
- ClinicalTrials.gov ID
- NCT00283621
- Acronym / sponsor ID
- ID02-326
- Conditions
- Sarcoma
- Keywords
- Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 2 Jun 2003 (actual)
- Primary completion
- 12 Apr 2006 (actual)
- Study completion
- 12 Apr 2006 (actual)
- First posted
- 30 Jan 2006 (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.
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
Detailed description
The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth Factors + Adriamycin/Ifosfamide | Experimental | Drug: Aranesp (darbepoetin alfa), Drug: Neulasta (pegfilgrastim), Drug: Adriamycin, Drug: IfosfamideGrowth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated
- Must be between 18-65 years of age
- Women of childbearing potential should use effective contraceptive measures
- Adequate hematologic, renal, and hepatic functions
- Karnofsky performance status above or equal to 80
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication
- Patients with metastatic disease to CNS
- Patients with significant cardiac abnormalities
- History of seizure disorder in the past 5 years
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 |
|---|---|---|
| Aranesp (darbepoetin alfa) | Drug | Growth Factors + Adriamycin/Ifosfamide |
| Neulasta (pegfilgrastim) | Drug | Growth Factors + Adriamycin/Ifosfamide |
| AdriamycinAlso: Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF | Drug | Growth Factors + Adriamycin/Ifosfamide |
| IfosfamideAlso: Ifex | Drug | Growth Factors + Adriamycin/Ifosfamide |
Primary outcome
CBC diff/platelet counts
Time frame: Monitored at least twice a week and daily during severe myelosuppression.
Iron Stores
Time frame: Blood drawn at baseline during cycle 3 and at the end of study.
Peripheral blood and bone marrows
Time frame: Performed at baseline and post treatment.
1 secondary outcome
Neurocognitive functions and Symptom burden assessment
Time frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Saroj Vadhan-Raj, M.D. principal investigator
UT MDAnderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim) and Adriamycin in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CBC diff/platelet counts (time frame: Monitored at least twice a week and daily during severe myelosuppression.). The study lists 3 primary outcomes in all. 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 7 Nov 2018.