The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer - Full Text View

Purpose

The purpose of this study is to compare the pharmacokinetic and safety characteristics of Taxotere® with Hospira docetaxel in patients with cancer.

Condition	Intervention	Phase
Cancer for Which Taxanes Are a Suitable Treatment Option.	Drug: European Taxotere Drug: American Taxotere Drug: Hospira Docetaxel Injection	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase I Double-blinded, Randomized Three-period, Three-treatment, Crossover Study to Compare the Intravenous Pharmacokinetic and Safety Characteristics of European Taxotere® and American Taxotere® With Hospira Docetaxel Injection Administered at a Therapeutic Dose in Cancer Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:

AUC (0-tlast); Cmax [ Time Frame: Day -21 through Day 57 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

T(1/2); Plasma Clearance, Vss [ Time Frame: Day -21 through Day 57 ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	June 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 European Taxotere (Taxotere EU) 60-100 mg/m2	Drug: European Taxotere 60 mg/m2 IV
Experimental: 3 Hospira Docetaxel Injection 60-100 mg/m2	Drug: Hospira Docetaxel Injection 60-100 mg/m2 IV
Active Comparator: 2 American Taxotere (Taxotere US) 60-100 mg/m2	Drug: American Taxotere 60-100 mg/m2 IV

Detailed Description:

No information is available on the pharmacokinetic characteristics, safety or efficacy of Hospira Docetaxel Injection. The primary purpose of this study therefore is to compare the pharmacokinetic characteristics of 60-100 mg/m² Hospira Docetaxel Injection, 60-100 mg/m² European Taxotere® (Taxotere® EU) and 60-100 mg/m² American Taxotere® (Taxotere® US) when administered as a 1 hour intravenous infusion in man. The secondary objective of this study will be to compare the safety and tolerability of Hospira Docetaxel Injection, Taxotere® EU and Taxotere® US. The study will also provide an opportunity to assess selected efficacy endpoints according to local practice after each cycle of treatment.

The study dosing regimen (60-100 mg/m², administered as a 1 hour intravenous infusion at 3 week intervals) and subject population (cancer patients for whom Taxotere® monotherapy would be a suitable treatment option) were selected on the basis of the licensed use of 60-100 mg/m² Taxotere®. The randomised crossover design was chosen to reduce the effect of intersubject variation.

Since Hospira Docetaxel Injection has not been administered to man there is no information on the risks associated with its clinical use. However the active ingredient of Hospira Docetaxel Injection is the same as that of Taxotere® and it is expected that Hospira Docetaxel Injection will exhibit a similar safety and tolerability profile.

An estimated 24 patients will be recruited at several UK sites and one Russian site to provide 19 evaluable patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent
Medically documented cancer for which Taxotere® monotherapy is a suitable treatment option
ECOG performance status 0 - 1
Haematological and serum chemical parameters in accordance with the protocol
Effective method of contraception as specified in the protocol
Willing and able to comply with the protocol

Exclusion Criteria:

Concomitant treatment with any other cytotoxic agent
Concomitant use of compounds that induce, inhibit or are metabolized by cytochrome P450
History or presence of any clinically in the opinion of the Investigator, would preclude inclusion in the study
Clinically significant vital signs or 12-lead ECG results
Participation in any other clinical trial using an investigational drug within the previous month
History of Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus
Recent or clinically significant history of drug or alcohol abuse
Insulin-dependent or unstable Diabetes Mellitus
History of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with Polysorbate 80
History of reaction to any drug containing polyethylene glycol 300 (PEG 300);
Pregnancy or lactation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268163

Locations

Russian Federation
N.N. Petrov Research Institute of Oncology
St. Petersburg, Russian Federation
United Kingdom
Christie Hospital, Manchester
Glasgow,, Cambridge, United Kingdom

Sponsors and Collaborators

Hospira, Inc.

Investigators

Principal Investigator:	M. Ranson	Christie Hospital, Manchester
Principal Investigator:	V Semiglazov	N.N. Petrov Research Institute of Oncology

More Information

No publications provided

Responsible Party:	Rodeina Challand, Hospira, Inc.
ClinicalTrials.gov Identifier:	NCT01268163 History of Changes
Other Study ID Numbers:	DOE061
Study First Received:	October 8, 2010
Last Updated:	December 28, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Russia: Ministry of Health of the Russian Federation

Keywords provided by Hospira, Inc.:

Docetaxel
Phase I
Pharmacokinetic
Bioequivalence

Additional relevant MeSH terms:

Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013