The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01268163
First received: October 8, 2010
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

The purpose of this study is to compare the pharmacokinetic and safety characteristics of European Taxotere® and American Taxotere® with Hospira Docetaxel injection 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 1, Double-blinded, Randomised, Multi-centre, 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:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Area under the concentration time curve from zero to last measured concentration (AUC[0-tlast]) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Maximum plasma concentration observed (Cmax) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration time curve from zero to infinity (AUC0-∞) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Terminal elimination half life (t1/2) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Elimination rate constant (Kel) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Total plasma clearance (CL) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Volume of distribution (Vss) [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]
  • Area under the concentration time curve for unbound docetaxel [ Time Frame: On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle). ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 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/m^2
Drug: European Taxotere®
60-100 mg/m^2 IV
Experimental: 3
Hospira Docetaxel Injection 60-100 mg/m^2
Drug: Hospira Docetaxel Injection
60-100 mg/m^2 IV
Active Comparator: 2
American Taxotere® (Taxotere US) 60-100 mg/m^2
Drug: American Taxotere®
60-100 mg/m^2 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 United Kingdom 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 given;
  • Have medically documented cancer for which Taxotere® monotherapy would be a suitable treatment option;
  • Aged ≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 - 1 (inclusive);
  • Haematological and serum chemical parameters that comply with the following criteria (based on local laboratory normal reference range):

    • Haemoglobin ≥9.5 g/dL
    • Leukocytes ≥3.0 x 10^9/L
    • Neutrophils ≥1.5 x 10^9/L
    • Platelets ≥100 x 10^9 L
    • Total bilirubin ≤2.0 x Upper Limit of Normal (ULN)
    • Aspartate aminotransferase (AST) ≤2.5 x ULN
    • Alanine aminotransferase (ALT) ≤2.5 x ULN
    • Alkaline phosphatase ≤4.0 x ULN
    • Serum creatinine ≤1.5 x ULN
  • Willing to use an effective method of contraception, i.e. intrauterine device (IUD), oral contraceptive, subdermal implant or double barrier (condom with a contraceptive sponge or contraceptive suppository), unless anatomically sterile, from screening until at least 12 weeks after last dose of Investigational Medicinal Product.
  • Willing and able to comply with the requirements of the protocol and available for the planned duration of the study.

Exclusion Criteria:

  • Concomitant treatment with any other cytotoxic agent;
  • Concomitant use of compounds that induce, inhibit or are metabolized by cytochrome P450, e.g. ciclosporin, ketoconazole, erythromycin, St John's Wort;
  • History or presence of any clinically significant findings that, in the opinion of the Investigator, would preclude inclusion in the study;
  • Clinically significant vital signs or 12-lead electrocardiogram (ECG) results, as judged by the Investigator;
  • Participation in any other clinical trial using an Investigational Medicinal Product 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Russian Federation
St. Petersburg, Russian Federation
United Kingdom
Cambridge, United Kingdom
Glasgow, United Kingdom
Manchester, 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: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01268163     History of Changes
Other Study ID Numbers: DOE061
Study First Received: October 8, 2010
Last Updated: July 23, 2015
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
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on July 26, 2015