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

Phase 2

Completed

• Conditions: Lung Cancer; Ovarian Cancer; Breast Cancer
• Interventions: Drug: carboplatin; Drug: paclitaxel; Drug: pegfilgrastim

• Registration Number: NCT00117442
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-08
• Study Completion: 2004-12
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim 6 mg	pegfilgrastim	Pegfilgrastim 6 mg given once for mobilization
Pegfilgrastim 12 mg	pegfilgrastim	Pegfilgrastim 12 mg given once for mobilization
Pegfilgrastim 18 mg	carboplatin	Pegfilgrastim 18 mg given once for mobilization
Pegfilgrastim 18 mg	paclitaxel	Pegfilgrastim 18 mg given once for mobilization
Pegfilgrastim 18 mg	pegfilgrastim	Pegfilgrastim 18 mg given once for mobilization
Filgrastim	carboplatin	Filgrastim given daily for mobilization
Filgrastim	paclitaxel	Filgrastim given daily for mobilization
Pegfilgrastim 12 mg	carboplatin	Pegfilgrastim 12 mg given once for mobilization
Pegfilgrastim 12 mg	paclitaxel	Pegfilgrastim 12 mg given once for mobilization
Pegfilgrastim 6 mg	carboplatin	Pegfilgrastim 6 mg given once for mobilization
Pegfilgrastim 6 mg	paclitaxel	Pegfilgrastim 6 mg given once for mobilization

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PBPC kinetics and response to chemotherapy treatment	Cycles 1-4