The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Docetaxel

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.