Treatment of hormone-refractory prostate cancer (HRPC) MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Trade Name: Taxotere 20 mg
Product Name: Taxotere 20 mg
Product Code: Docetaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Current Sponsor code: Docetaxe
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • adenocarcinoma of the prostate confirmed by histology or cytology • metastasized adenocarcinoma of the prostate that is refractory to hormone treatment, ie, that does no longer respond to hormone therapy and/or the current treatment with estramustine • documented progression under the last therapy (definite PSA-increase that is confirmed by 2 subsequent measurements separated by at least 2 weeks, or increase of measurable lesions by at least 25% that is confirmed by radiological measurements) • previous hormone therapy • ECOG performance status = 60%) • adequate hematological, cardial and hepatic function defined by the following parameters: - absolute neutrophil count >= 2 x 109/l - thrombocytes >= 100 x 109/l - hemoglobin >=10 g/dl (6.2 mmol/l) - total serum bilirubin = 12 weeks • written informed consent • age >= 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • previous therapy with isotopes • previous chemotherapy (except estramustine) • radiotherapy in the 4 weeks prior to enrollment • previous radiotherapy if this concerned all lesions that are used for the evaluation of tumor response • previous radiotherapy if this concerned more than 25% of bone marrow • previous or concomitant neoplasm (except curatively treated in situ carcinoma and basal cell carcinomas of the skin as well as curatively treated neoplasms without recurrence in the 5 years prior to enrollment • previous or current cerebral metastases or leptomeningeal involvement • current peripheral neuropathy >= grade 2 (CTCAE 3.0) • renal inusufficiancy requiring dialysis • chronic diarrhea (now or in medical history) • other relevant concomitant diseases: a) congestive heart failure or uncontrolled angina pectoris, previous myocardial infarction within 6 months prior to enrollment, uncontrolled arterial hypertension or arrhythmias b) known significant neurological or psychiatric diseases including dementia and epileptic seizures c) active infections requiring intravenous administration of antibiotics d) ulcerations, not stable diabetes mellitus or other contraindications with regard to the administration of high doses of corticosteroids e) untreated vena-cava-syndrome f) known ascites or pericardial effusion g) known symptomatic pleural effusion that requires tapping • concomitant treatment with other anti-tumor therapies except LHRH-agonists in a constant dose (for at least 4 weeks prior to enrollment) which should be continued • participation in a clinical trial within 30 days prior to enrollment • being anable to complie with therapy and investigations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is the comparison between the continuous therapy and the intermittent therapy. It should be shown that the intermittent therapy is not inferior to the continuous therapy with regard to the primary criterion, i.e. the 1-year survival rate.;Secondary Objective: Secondary objectives are comparisons between both treatment arms concerning - median survival-rate, median time-to-progression (TTP) and median time-to-failure (TTF). (The TTF is defined by the time until discontinuation of the treatment according to the study protocol. Within the intermittent arm, a progression occurring during the interval without therapy will not be included in the calculation of the TTP as an end point if the resumption of the treatment can prevent the occurrence of another progression "under treatment".) - the proportion of the patients suffering from adverse events > grade 2 according to CTCAE 3.0 which have been caused by the therapy. In addition, an exploratory comparison is planned between a weekly application and a three-weekly application with regard to all objectives of the trial. ;Primary end point(s): -Progression of the disease under treatment -Occurrence of adverse events which are not allowing the continution of the treatment according to the study protocol. -The patient's request -Other reasons for which a continuation of the treatment according to the study protocol would not be in the patient's best intest. | — |
Countries
Germany
Outcome results
None listed