A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
- Histologically verified adenocarcinoma of the prostate.
- Hormone refractory prostate cancer (HRPC) defined as progression during previous
anti-hormone treatment. Patients must have been off previous anti-androgen therapy
for more than 4 weeks.
- Stage IV disease (verified by imaging or clinical examination).
- PSA > 10 microgram/l.
- PSA progression defined as a > 25% increase between two independent measurements
performed with a 1-month interval or more after discontinuation of anti-androgen
- Castrate level of testosterone (< 50 ng).
- No previous oestrogen or steroid as metastatic prostate cancer treatment.
- Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal
limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
- Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
- Satisfactory haematologic function defined as ANC >1.5 x 10^9/l, leucocytes >3.0 x
10^9/l, thrombocytes ≥ 100 x 10^9/l, haemoglobin > 7 mmol/l
- ECOG performance status ≤ 2.
- Life expectancy > 3 months.
- Patient must be able to adhere to protocol requirements.
- Written informed consent.
- > 18 years of age.
- Previous prostate cancer treatment with oestrogens or steroid hormones.
- Previous chemotherapy.
- Previous treatment with systemic radioactive isotopes.
- Bisphosphonate treatment (concomitant).
- Radiation therapy covering more than 25% of the bone marrow producing area.
- Other serious coincidental and/or concomitant medical condition.
- Symptomatic cerebral metastases.
- Other previous or current malignant disease, excluding *adequately treated and cured
planocellular skin carcinoma; or *other cancer assessed to carry minimal risk of
- ECOG performance status > 2.