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Completed

NCT Number: NCT00117442

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

Chemotherapy

paclitaxel

Drug

chemotherapy

pegfilgrastim

Drug

Growth factor for mobilization

Primary outcomes

  1. PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.

    Time frame: Cycle 0, and through 4 cycles

Secondary outcomes

  1. PBPC kinetics and response to chemotherapy treatment

    Time frame: Cycles 1-4

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jul 7, 2005
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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