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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117442 |
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 |
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 |
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
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Filgrastim: Active Comparator
Filgrastim given daily for mobilization
|
Drug: carboplatin
Chemotherapy
Drug: paclitaxel
chemotherapy
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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
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
solid tumour unknown primary tumour carboplatin paclitaxel |
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 |
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 |