None listed
Conditions
Interventions
Chemotherapy is given twice every three weeks, ie. Paclitaxel 40mg/m2 IV and Vinorelbine 20mg/m2 IV. The duration of treatment: as long as the treatment is working, or the side effects are tolerable.
Sponsors
Bristol Myers Squibb
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Hormone-refractory prostate cancer with metastases documented by bone scan and/or CT scan, with rising PSA and/or progressive metastatic disease with serum testosterone < 3.5 nmol/L. - Patients who have not had bilateral orchidectomy should continue therapy with a Luteinizing hormone-releasing hormone analogue. Antiandrogens should be ceased at least 28 days prior to study entry. - Adequate bone marrow function: absolute neutrophil count (ANC) at least 1.5 X 109/L and platelets at least 100 X 109/L. - Adequate renal function: serum creatinine less than or equal to 200µmol/L. - Adequate liver function: bilirubin less than or equal to 20µmol/L and AST/ALT less than or equal to 5 X upper limit of normal. - ECOG performance status 0-2. - Not more than one previous line of chemotherapy (prior exposure to vinorelbine and/or taxanes not allowable).
Exclusion criteria
Prior radiotherapy within 21 days - Prior radioactive strontium within 42 days. - Concurrent treatment with other investigational agents.
Outcome results
None listed