A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood

An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117442

Enrollment

Registered

2005-07-07

Start date

2002-08-31

Completion date

2004-12-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lung Cancer, Ovarian Cancer

Keywords

solid tumour, unknown primary tumour, carboplatin, paclitaxel

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.

Interventions

DRUGpaclitaxel

chemotherapy

DRUGpegfilgrastim

Growth factor for mobilization

DRUGcarboplatin

Chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

- Pathologically confirmed diagnosis of malignancy (solid tumour) suitable for treatment with intensified carboplatin and paclitaxel - Previously untreated with chemotherapy or radiotherapy - ECOG performance status 0 to 2 inclusive - Life expectancy greater than or equal to 12 weeks - ANC greater than or equal to 2.0 x 10\^9/L, platelets greater than 100 x 10\^9/L - Glomerular filtration rate greater than 60 mL/min

Exclusion criteria

- Active infection requiring treatment with systemic (IV or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of randomisation - Known to be HIV positive - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History of impaired cardiac status \[e.g., severe heart disease (NYHA greater than 2), cardiomyopathy, or congestive heart failure\] - Bone marrow involvement of disease - Major surgery within 2 weeks before randomisation - Known sensitivity to E. coli derived drug products (e.g., filgrastim) - Previous exposure to pegfilgrastim

Design outcomes

Primary

Measure	Time frame
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.	Cycle 0, and through 4 cycles

Secondary

Measure	Time frame
PBPC kinetics and response to chemotherapy treatment	Cycles 1-4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026