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

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