Prostate Cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Newcastle Upon Tyne Hospitals NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients will be included in the study if they fulfill the following criteria: 1. Age 18. 2. Men with female partners of child bearing potential must be willing to take adequate contraception. 3. Histologic proven prostate adenocarcinoma presenting with metastatic disease. 4. Karnofsky Performance status 70% (see Appendix C). 5. Life expectancy > 12 months. 6. Gleason Score of 8-10 or Gleason = 7 with proven site of metastasis Or Gleason score 7 with evidence of either 3 or more hot spots on bone scan or evidence of soft tissue metastasis Or Prostate Specific Antigen > 50 7. Adequate renal function as indicated by: Serum Creatinine 9 g/dL ( 6.0mmol/L) Neutrophils 1.5 x 103/mm3 WBC 4.0 x 109/L 12. Written Informed Consent from the patient. 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: 1. Prior Cytotoxic therapy 2. Prior radiotherapy to greater than 25% of bone marrow. 3. Prior malignancy except adaquately treated basal cell or sqamous cell skin cancer. 4. Brain or leptomeningeal involvement. 5. Symptomatic peripheral neuropathy equal to or greater than grade 2 NCI Common Toxicity Criteria 6. Other serious illness or medical condition a) Congestive heart failure even if uncontrolled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or arrythmias. b) Active uncontrolled infection. c) Peptic ulcer, unstable diabetes mellitus or other contraindications against the use of steroids. d) Auto-immune disease (Lupus, sclerodermia, rheumatoid polyarthritis). 7. Any condition (medical, social, psychological) which would prevent adequate follow-up. 8. The use of any investigational agent 30 days before enrolment in the study. 9. Treatment with systemic cortico-steroids used for other reasons than specified by this protocol. 10. Treatment with bisphosphonates must be stopped prior to randomisation.?? For how long 11. Patient is unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, tolerance, efficacy, and response to Taxotere 75mg/m2 given every 3 weeks as a monotherapy for Patients With High Risk Metastatic Prostate Cancer.;Secondary Objective: a) Time to Progression b) Overall Survival c) Quality of Life d) Tumour Profiling ;Primary end point(s): Response rate | — |
Countries
United Kingdom
Outcome results
None listed