Hormone refractory prostate cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Solution for infusion
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Concentration unit: mg/m2 milligram(s)/square meter
Con
Sponsors
VU Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. 18 years and above. 2. Histologically proven hormone refractory prostate adenocarcinoma. 3. PSA and/or clinical response on prior docetaxel-based chemotherapy with a progression free interval of over 3 months. 4. Last PSA value = 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent) 5. Patients without surgical castration must continue on LHRH agonist therapy 6. ECOG performance status = 2 7. Gleason score 8-10 8. Adequate haematological, liver and renal function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 1 line of chemotherapy. 2. Prior platinum chemotherapy. 3. Radiotherapy within 2 weeks prior to treatment start. 4. Uncontrolled hypercalcemia. 5. Evidence of symptomatic brain and leptomeningeal metastatic disease. 6. Previous or concurrent malignancies at other sites (except basal squamous cell carcinoma of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first: o PSA progression o Progressive disease according to RECIST when measurable disease ;Secondary Objective: • Toxicity profile. • PSA response and duration of PSA response. • Objective tumor response when measurable disease. • Survival. • QoL. ;Primary end point(s): Progressive disease | — |
Countries
Netherlands
Outcome results
None listed