None listed
Conditions
Brief summary
The ProTaT trial is a phase II trial evaluating the safety and activity of the combination of docetaxel (Taxotere), prednisone and Thalidomide in men with metastatic hormone refractory prostae cancer. The hypothesis is that the combination of a standard systemic therapy, docetaxel, with and antiangiogenic agent may improve the response rate in patients with this disease.
Interventions
All patients will receive treatment with docetaxel 75 mg/msquared intravenously every 3 weeks (1 cycle). On day 1 patients will commence a daily dose of prednisone 10 mg orally and a 200 mg oral dose of thalidomide given daily. Prophylactic enoxaparin at a dose of 40 mg subcutaneous will be administered daily. Patients will continue to receive treatment until disease progression, patient intolerance or withdraw of consent. Maximum number of cycles is 10. After study treatment discontinuation,
All patients will receive treatment with docetaxel 75 mg/msquared intravenously every 3 weeks (1 cycle). On day 1 patients will commence a daily dose of prednisone 10 mg orally and a 200 mg oral dose of thalidomide given daily. Prophylactic enoxaparin at a dose of 40 mg subcutaneous will be administered daily. Patients will continue to receive treatment until disease progression, patient intolerance or withdraw of consent. Maximum number of cycles is 10. After study treatment discontinuation, patients will be treated by their physicians as determined by usual practice and followed for survival.
Sponsors
Royal North Shore Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically/cytologically proven prostate adenocarcinoma2. ALl patients are males, aged 18 years or more and must have prostate adenocarcinoma that is responsive or refractory to hormone therpay.3. Prior treatment with crticosteroids is allowed.4. life expectancy greater or equal to 3 months.5. prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.6. ECOG 0-27. Informed consent signed
Exclusion criteria
1. Prior cytotoxic chemotherapy (except monotherapy with estramustine)2. prior isotope therapy3. prior radiotherapy to >25% of bone marrow (whole pelvic radiation is not allowed)4. known brain leptomeningeal involvement.5. Other malignancy6. Uncontrolled medical condition7. Prior Deep venous thrombosis or pulmonary embolism
Outcome results
None listed