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Study Complete
Sponsor ID
20010191

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

Sponsor ID
20010191
Clinicaltrials.gov ID
NCT00117442
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
pegfilgrastim
Type
Interventional
Masking
None (Open Label)
Enrollment
61
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Cycle 0, and through 4 cycles

Secondary Outcome Measures

PBPC kinetics and response to chemotherapy treatment

Timeframe: Cycles 1-4

Locations

No locations found.
Study Info
Age
18 - 65 Years
Condition
  • Breast Cancer
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  • Lung Cancer - General
  • Ovarian Cancer
    • Sex
    All
    Trial Dates
    Aug 2002 - Aug 2004
    Inclusion and Exclusion Criteria
    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