NCT00283621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2006

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

2.9 years

First QC Date

January 27, 2006

Last Update Submit

November 5, 2018

Conditions

Sarcoma

Keywords

AranespDarbepoetin AlfaPegfilgrastimNeulastaSarcomaAdriamycinDoxorubicin HydrocholorideAdriamycin PFSAdriamycin RDFIfosfamide

Outcome Measures

Primary Outcomes (3)

  • CBC diff/platelet counts

    Monitored at least twice a week and daily during severe myelosuppression.

  • Iron Stores

    Blood drawn at baseline during cycle 3 and at the end of study.

  • Peripheral blood and bone marrows

    Performed at baseline and post treatment.

Secondary Outcomes (1)

  • Neurocognitive functions and Symptom burden assessment

    Assessed at baseline, after 3 cycles of treatment and at the end of the study.

Study Arms (1)

Growth Factors + Adriamycin/Ifosfamide

EXPERIMENTAL

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

Drug: Aranesp (darbepoetin alfa)Drug: Neulasta (pegfilgrastim)Drug: AdriamycinDrug: Ifosfamide

Interventions

Aranesp (darbepoetin alfa)DRUG
Growth Factors + Adriamycin/Ifosfamide
Neulasta (pegfilgrastim)DRUG
Growth Factors + Adriamycin/Ifosfamide
AdriamycinDRUG
Also known as: Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF
Growth Factors + Adriamycin/Ifosfamide
IfosfamideDRUG
Also known as: Ifex
Growth Factors + Adriamycin/Ifosfamide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MDAnderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

Darbepoetin alfapegfilgrastimDoxorubicinIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Saroj Vadhan-Raj, M.D.

    UT MDAnderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

June 2, 2003

Primary Completion

April 12, 2006

Study Completion

April 12, 2006

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

US(1)