A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
- Conditions
- advanced or recurrent breast cancer patients.
- Registration Number
- JPRN-UMIN000015820
- Lead Sponsor
- Okayama University Hospital Center for Innovative Clinical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 6
Not provided
(1)Patients with a history of hypersensitivity to Docetaxel, alcohol or any drug product containing Polysorbate 80 (2)Patients with a mental disease or patients who are incapable of participating in the trial due to psychiatric symptoms (3)Patients with any uncontrollable infection (e.g., fungi, virus, bacteria) (4)Patients with unstable or untreated metastasis in the central nervous system (5)Patients with any uncontrolled heart disease including cadiomyopathy, NYHA grade III or IV heart diseases, arrhythmia, unstable angina and myocardial infarction (6)Patients with a history of treatment with Docetaxel for advanced or recurrent breast cancer. However, patients with recurrent disease can participate if the disease recurred at least 6 months after receiving the last dose of Docetaxel in a pre- and/or post-operative adjuvant chemotherapy (7)Patients who cannot tolerate pretreatment with Dexamethasone because steroids are clinically contraindicated (8)Patients with a history of or concurrent malignant tumor (9)Patients positive for anti-human immunodeficiency virus antibody, those with active chronic type B or type C hepatitis. (10)Patients with concurrent peripheral neuropathy of CTCAE (v 4.0) grade 2 or higher (11)Women who are pregnant, possibly pregnant or are lactating (12)Premenopausal, possibly pregnant female patients or fertile male patients who do not agree to practice contraception using medically approved methods from 2 weeks before the start of administration of the investigational product to 120 days after the completion of administration of the investigational product (13)Patients who cannot continue the treatment under hospitalization for at least 15 days, beginning from the start of administration of the investigational product in the first course (14)Patients otherwise unsuitable for this clinical trial in the opinion of the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety
- Secondary Outcome Measures
Name Time Method pharmacokinetics pharmacodynamics efficacy