Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

November 5, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MDAnderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CBC diff/platelet counts
Time Frame: Monitored at least twice a week and daily during severe myelosuppression.
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.
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.
Performed at baseline and post treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurocognitive functions and Symptom burden assessment
Time Frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study.
Assessed at baseline, after 3 cycles of treatment and at the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Amgen

Investigators

  • Principal Investigator: Saroj Vadhan-Raj, M.D., UT MDAnderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2003

Primary Completion (Actual)

April 12, 2006

Study Completion (Actual)

April 12, 2006

Study Registration Dates

First Submitted

January 27, 2006

First Submitted That Met QC Criteria

January 27, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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