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Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

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. Identifier: NCT00283621
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : November 7, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: Aranesp (darbepoetin alfa) Drug: Neulasta (pegfilgrastim) Drug: Adriamycin Drug: Ifosfamide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Actual Study Start Date : June 2, 2003
Actual Primary Completion Date : April 12, 2006
Actual Study Completion Date : April 12, 2006

Arm Intervention/treatment
Experimental: Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Drug: Aranesp (darbepoetin alfa)
Drug: Neulasta (pegfilgrastim)
Drug: Adriamycin
Other Names:
  • Doxorubicin Hydrocholoride
  • Adriamycin PFS
  • Adriamycin RDF

Drug: Ifosfamide
Other Name: Ifex

Primary Outcome Measures :
  1. CBC diff/platelet counts [ Time Frame: Monitored at least twice a week and daily during severe myelosuppression. ]
  2. Iron Stores [ Time Frame: Blood drawn at baseline during cycle 3 and at the end of study. ]
  3. Peripheral blood and bone marrows [ Time Frame: Performed at baseline and post treatment. ]

Secondary Outcome Measures :
  1. Neurocognitive functions and Symptom burden assessment [ Time Frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283621

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United States, Texas
UT MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Saroj Vadhan-Raj, M.D. UT MDAnderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00283621    
Other Study ID Numbers: ID02-326
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by M.D. Anderson Cancer Center:
Darbepoetin Alfa
Doxorubicin Hydrocholoride
Adriamycin PFS
Adriamycin RDF
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Darbepoetin alfa
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents