Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00117442
  Purpose

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 Intervention Phase
Breast Cancer
Lung Cancer
Ovarian Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: pegfilgrastim
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Ovarian Cancer
Drug Information available for: Carboplatin Paclitaxel Pegfilgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time. [ Time Frame: Cycle 0, and through 4 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PBPC kinetics and response to chemotherapy treatment [ Time Frame: Cycles 1-4 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: August 2002
Study Completion Date: December 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pegfilgrastim 18 mg: Experimental
Pegfilgrastim 18 mg given once for mobilization
Drug: carboplatin
Chemotherapy
Drug: paclitaxel
chemotherapy
Drug: pegfilgrastim
Growth factor for mobilization
Filgrastim: Active Comparator
Filgrastim given daily for mobilization
Drug: carboplatin
Chemotherapy
Drug: paclitaxel
chemotherapy
Pegfilgrastim 12 mg: Experimental
Pegfilgrastim 12 mg given once for mobilization
Drug: carboplatin
Chemotherapy
Drug: paclitaxel
chemotherapy
Drug: pegfilgrastim
Growth factor for mobilization
Pegfilgrastim 6 mg: Experimental
Pegfilgrastim 6 mg given once for mobilization
Drug: carboplatin
Chemotherapy
Drug: paclitaxel
chemotherapy
Drug: pegfilgrastim
Growth factor for mobilization

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117442

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20010191
Study First Received: June 30, 2005
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00117442  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:
solid tumour
unknown primary tumour
carboplatin
paclitaxel

Study placed in the following topic categories:
Thoracic Neoplasms
Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Genital Diseases, Female
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009