Prostatic Neoplasms
Conditions
Brief summary
Primary objectives: * To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting. Secondary objectives: * To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC * To evaluate PSA response (PSA: Prostate Specific Antigen) * To evaluate symptomatic response * To evaluate Quality of life * To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
Interventions
DRUGdocetaxel
Sponsors
Canadian Urologic Oncology Group
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically/cytologically proven prostate adenocarcinoma * Progression or non response with previous chemotherapy regimen (excluding Taxotere®) * Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine * Castration levels of testosterone (\<50 ng/dL ) * ECOG performance status 0-2 * Laboratory requirements : 1. Hematology: * Neutrophils ≥ 1.5 x 10\^9/L * Hemoglobin \> 10 g/dL (prior transfusion permitted). * Platelets ≥ 100 x 10\^9/L 2. Hepatic function: * Total bilirubin \< the upper-normal limit of the institution. * ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution. 3. Renal function: * Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1) * No severe or uncontrolled disease
Exclusion criteria
* Chemotherapy within the last 4 weeks * Anti-androgen therapy within the last 4 weeks. * Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for \>2 years. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. * Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry. * Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire) | During the Study Conduct |
Secondary
| Measure | Time frame |
|---|---|
| PSA (PSA response and PSA progression | During the study conduct |
| Tumor lesion assessment, | During the study conduct |
| Analgesics (assessed by Pain Medication Log) | During the study conduct |
| Progression-free survival | During the study conduct |
| Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams. | from the inform consent signed up to the end of the study |
| Overall survival | During the study conduct |
Outcome results
None listed