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

May 9, 2013 updated by: Amgen

An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegfilgrastim 18 mg
Pegfilgrastim 18 mg given once for mobilization
chemotherapy
Chemotherapy
Growth factor for mobilization
Active Comparator: Filgrastim
Filgrastim given daily for mobilization
chemotherapy
Chemotherapy
Experimental: Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for mobilization
chemotherapy
Chemotherapy
Growth factor for mobilization
Experimental: Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for mobilization
chemotherapy
Chemotherapy
Growth factor for mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.
Time Frame: Cycle 0, and through 4 cycles
Cycle 0, and through 4 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
PBPC kinetics and response to chemotherapy treatment
Time Frame: Cycles 1-4
Cycles 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 7, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on paclitaxel

3
Subscribe