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Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283621
First Posted: January 30, 2006
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
January 27, 2006
January 30, 2006
August 1, 2012
November 2002
April 2006   (Final data collection date for primary outcome measure)
  • 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. ]
  • Cbc diff/platelet counts monitored at least twice a week and daily during severe myelosuppression.
  • Iron stores drawn at baseline during cycle 3 and at the end of study.
  • Peripheral blood and bone marrows performed at baseline and post treatment.
Complete list of historical versions of study NCT00283621 on ClinicalTrials.gov Archive Site
Neurocognitive functions and Symptom burden assessment [ Time Frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study. ]
Neurocognitive functions and Symptom burden assessment assessed at baseline, after 3 cycles of treatment and at the end of the study.
Not Provided
Not Provided
 
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Sarcoma
  • Drug: Aranesp (darbepoetin alfa)
  • Drug: Neulasta (pegfilgrastim)
  • Drug: Adriamycin
    Other Names:
    • Doxorubicin Hydrocholoride
    • Adriamycin PFS
    • Adriamycin RDF
  • Drug: Ifosfamide
    Other Name: Ifex
Experimental: Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Interventions:
  • Drug: Aranesp (darbepoetin alfa)
  • Drug: Neulasta (pegfilgrastim)
  • Drug: Adriamycin
  • Drug: Ifosfamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2006
April 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00283621
ID02-326
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Amgen
Principal Investigator: Saroj Vadhan-Raj, M.D. UT MDAnderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP