Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00283621
First received: January 27, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Sarcoma
Drug: Aranesp (darbepoetin alfa)
Drug: Neulasta (pegfilgrastim)
Drug: Adriamycin
Drug: Ifosfamide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • CBC diff/platelet counts [ Time Frame: Monitored at least twice a week and daily during severe myelosuppression. ] [ Designated as safety issue: No ]
  • Iron Stores [ Time Frame: Blood drawn at baseline during cycle 3 and at the end of study. ] [ Designated as safety issue: No ]
  • Peripheral blood and bone marrows [ Time Frame: Performed at baseline and post treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurocognitive functions and Symptom burden assessment [ Time Frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283621

Locations
United States, Texas
UT MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
Principal Investigator: Saroj Vadhan-Raj, M.D. UT MDAnderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00283621     History of Changes
Other Study ID Numbers: ID02-326
Study First Received: January 27, 2006
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Aranesp
Darbepoetin Alfa
Pegfilgrastim
Neulasta
Sarcoma
Adriamycin
Doxorubicin Hydrocholoride
Adriamycin PFS
Adriamycin RDF
Ifosfamide

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Darbepoetin alfa
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Hematinics
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014