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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Lung Cancer, Ovarian Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel
* Drug: pegfilgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegfilgrastim 18 mg<br>Pegfilgrastim 18 mg given once for mobilization | Drug: carboplatin<br>* Chemotherapy<br>Drug: paclitaxel<br>* chemotherapy<br>Drug: pegfilgrastim<br>* Growth factor for mobilization<br>|
| Active Comparator: Filgrastim<br>Filgrastim given daily for mobilization | Drug: carboplatin<br>* Chemotherapy<br>Drug: paclitaxel<br>* chemotherapy<br>|
| Experimental: Pegfilgrastim 12 mg<br>Pegfilgrastim 12 mg given once for mobilization | Drug: carboplatin<br>* Chemotherapy<br>Drug: paclitaxel<br>* chemotherapy<br>Drug: pegfilgrastim<br>* Growth factor for mobilization<br>|
| Experimental: Pegfilgrastim 6 mg<br>Pegfilgrastim 6 mg given once for mobilization | Drug: carboplatin<br>* Chemotherapy<br>Drug: paclitaxel<br>* chemotherapy<br>Drug: pegfilgrastim<br>* Growth factor for mobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time. |  | Cycle 0, and through 4 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PBPC kinetics and response to chemotherapy treatment |  | Cycles 1-4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumour, unknown primary tumour, carboplatin, paclitaxel