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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00117442

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Lung Cancer Ovarian Cancer	Drug: carboplatin Drug: paclitaxel Drug: pegfilgrastim	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pegfilgrastim 18 mg Pegfilgrastim 18 mg given once for mobilization	Drug: carboplatin Chemotherapy Drug: paclitaxel chemotherapy Drug: pegfilgrastim Growth factor for mobilization
Active Comparator: Filgrastim Filgrastim given daily for mobilization	Drug: carboplatin Chemotherapy Drug: paclitaxel chemotherapy
Experimental: Pegfilgrastim 12 mg Pegfilgrastim 12 mg given once for mobilization	Drug: carboplatin Chemotherapy Drug: paclitaxel chemotherapy Drug: pegfilgrastim Growth factor for mobilization
Experimental: Pegfilgrastim 6 mg Pegfilgrastim 6 mg given once for mobilization	Drug: carboplatin Chemotherapy Drug: paclitaxel chemotherapy Drug: pegfilgrastim Growth factor for mobilization

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

PBPC kinetics and response to chemotherapy treatment [Cycles 1-4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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