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

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ClinicalTrials.gov Identifier: NCT00117442
Recruitment Status : Completed
First Posted : July 7, 2005
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 7, 2005
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE August 2002
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time. [ Time Frame: Cycle 0, and through 4 cycles ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00117442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
PBPC kinetics and response to chemotherapy treatment [ Time Frame: Cycles 1-4 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
Official Title  ICMJE An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Lung Cancer
  • Ovarian Cancer
Intervention  ICMJE
  • Drug: carboplatin
    Chemotherapy
  • Drug: paclitaxel
    chemotherapy
  • Drug: pegfilgrastim
    Growth factor for mobilization
Study Arms  ICMJE
  • Experimental: Pegfilgrastim 18 mg
    Pegfilgrastim 18 mg given once for mobilization
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: pegfilgrastim
  • Active Comparator: Filgrastim
    Filgrastim given daily for mobilization
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Pegfilgrastim 12 mg
    Pegfilgrastim 12 mg given once for mobilization
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: pegfilgrastim
  • Experimental: Pegfilgrastim 6 mg
    Pegfilgrastim 6 mg given once for mobilization
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: pegfilgrastim
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2008)
61
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00117442
Other Study ID Numbers  ICMJE 20010191
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP