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

Amgen

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer

Treatments: Drug: paclitaxel; Drug: carboplatin; Drug: pegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117442

20010191

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

Pegfilgrastim 18 mg

Experimental group

Description:

Pegfilgrastim 18 mg given once for mobilization

Treatment:

Drug: pegfilgrastim

Drug: paclitaxel

Drug: carboplatin

Filgrastim

Active Comparator group

Description:

Filgrastim given daily for mobilization

Treatment:

Drug: paclitaxel

Drug: carboplatin

Pegfilgrastim 12 mg

Experimental group

Description:

Pegfilgrastim 12 mg given once for mobilization

Treatment:

Drug: pegfilgrastim

Drug: paclitaxel

Drug: carboplatin

Pegfilgrastim 6 mg

Experimental group

Description:

Pegfilgrastim 6 mg given once for mobilization

Treatment:

Drug: pegfilgrastim

Drug: paclitaxel

Drug: carboplatin