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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00117442
First received: June 30, 2005
Last updated: May 9, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

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

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00117442     History of Changes
Other Study ID Numbers: 20010191
Study First Received: June 30, 2005
Last Updated: May 9, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014