Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-02

Study Completion Date

2006-04-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Growth Factors + Adriamycin/Ifosfamide

Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)

Group Type EXPERIMENTAL

Aranesp (darbepoetin alfa)

Intervention Type DRUG

Neulasta (pegfilgrastim)

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Interventions

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Aranesp (darbepoetin alfa)

Intervention Type DRUG

Neulasta (pegfilgrastim)

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Other Intervention Names

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Doxorubicin Hydrocholoride Adriamycin PFS Adriamycin RDF Ifex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes