NCT00117442

Brief Summary

The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole blood.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_2 breast-cancer

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

August 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

June 30, 2005

Last Update Submit

May 9, 2013

Conditions

Breast CancerLung CancerOvarian Cancer

Keywords

solid tumourunknown primary tumourcarboplatinpaclitaxel

Outcome Measures

Primary Outcomes (1)

  • PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.

    Cycle 0, and through 4 cycles

Secondary Outcomes (1)

  • PBPC kinetics and response to chemotherapy treatment

    Cycles 1-4

Study Arms (4)

Pegfilgrastim 18 mg

EXPERIMENTAL

Pegfilgrastim 18 mg given once for mobilization

Drug: carboplatinDrug: paclitaxelDrug: pegfilgrastim

Filgrastim

ACTIVE COMPARATOR

Filgrastim given daily for mobilization

Drug: carboplatinDrug: paclitaxel

Pegfilgrastim 12 mg

EXPERIMENTAL

Pegfilgrastim 12 mg given once for mobilization

Drug: carboplatinDrug: paclitaxelDrug: pegfilgrastim

Pegfilgrastim 6 mg

EXPERIMENTAL

Pegfilgrastim 6 mg given once for mobilization

Drug: carboplatinDrug: paclitaxelDrug: pegfilgrastim

Interventions

carboplatinDRUG

Chemotherapy

FilgrastimPegfilgrastim 12 mgPegfilgrastim 18 mgPegfilgrastim 6 mg
paclitaxelDRUG

chemotherapy

FilgrastimPegfilgrastim 12 mgPegfilgrastim 18 mgPegfilgrastim 6 mg
pegfilgrastimDRUG

Growth factor for mobilization

Pegfilgrastim 12 mgPegfilgrastim 18 mgPegfilgrastim 6 mg

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Willis F, Theti D, Dean S, Bacon P, Baker N, Pettengell R. Pegfilgrastim successfully mobilizes megakaryocyte progenitors into the peripheral blood in subjects with solid tumours. Bone Marrow Transplant. 2008 Aug;42(3):167-73. doi: 10.1038/bmt.2008.147. Epub 2008 May 26.

    PMID: 18500375RESULT

  • Willis F, Woll P, Theti D, Jamali H, Bacon P, Baker N, Pettengell R. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone Marrow Transplant. 2009 Jun;43(12):927-34. doi: 10.1038/bmt.2008.411. Epub 2009 Jan 26.

    PMID: 19169289RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsOvarian Neoplasms

Interventions

CarboplatinPaclitaxelpegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

August 1, 2002

Primary Completion

August 1, 2004

Study Completion

December 1, 2004

Last Updated

May 13, 2013

Record last verified: 2013-05