Back to resultsAranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Primary Purpose
Sarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aranesp (darbepoetin alfa)
Neulasta (pegfilgrastim)
Adriamycin
Ifosfamide
Sponsored by
About this trial
This is an interventional prevention trial for Sarcoma focused on measuring Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF, Ifosfamide
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Sites / Locations
- UT MDAnderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Growth Factors + Adriamycin/Ifosfamide
Arm Description
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Outcomes
Primary Outcome Measures
CBC diff/platelet counts
Iron Stores
Peripheral blood and bone marrows
Secondary Outcome Measures
Neurocognitive functions and Symptom burden assessment
Full Information
NCT ID
NCT00283621
First Posted
January 27, 2006
Last Updated
November 5, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00283621
Brief Title
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Official Title
A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2003 (Actual)
Primary Completion Date
April 12, 2006 (Actual)
Study Completion Date
April 12, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF, Ifosfamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Growth Factors + Adriamycin/Ifosfamide
Arm Type
Experimental
Arm Description
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Intervention Type
Drug
Intervention Name(s)
Aranesp (darbepoetin alfa)
Intervention Type
Drug
Intervention Name(s)
Neulasta (pegfilgrastim)
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Other Intervention Name(s)
Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Ifex
Primary Outcome Measure Information:
Title
CBC diff/platelet counts
Time Frame
Monitored at least twice a week and daily during severe myelosuppression.
Title
Iron Stores
Time Frame
Blood drawn at baseline during cycle 3 and at the end of study.
Title
Peripheral blood and bone marrows
Time Frame
Performed at baseline and post treatment.
Secondary Outcome Measure Information:
Title
Neurocognitive functions and Symptom burden assessment
Time Frame
Assessed at baseline, after 3 cycles of treatment and at the end of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saroj Vadhan-Raj, M.D.
Organizational Affiliation
UT MDAnderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MDAnderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center
Learn more about this trial
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
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