Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate
- Patients with histologic proof of adenocarcinoma of the prostate and must have failed
conventional hormonal therapy.
- Patients must have osteoblastic bone metastases. At least one osteoblastic lesion
must be documented by plain film. Patients with mixed or osteolytic bone metastases
must have a biopsy to exclude histologic variants of prostate cancer or metastasis
from another primary (for phase II only).
- Patients must have evidence of progression of disease as demonstrated by 2
consecutive rise in PSA (an absolute change of at least 1 ng/mL) over 4 weeks.
- Patients on flutamide, nilutamide, or bicalutamide should be discontinued from
flutamide or nilutamide and bicalutamide for at least 4 weeks and 8 weeks,
- Patients must have an expected survival of at least three months and a Zubrod
performance status of < 2 (Zubrod scale; Appendix B).
- Patients may receive no concurrent chemotherapy or immunotherapy.
- Patients must have castrate serum testosterone levels (< 30 ng/dl). For patients who
are medically castrated, lutenizing hormone releasing hormone analog must continue to
maintain testicular suppression.
- Patients must have adequate bone marrow function defined as an absolute peripheral
granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3; adequate
hepatic function defined with a bilirubin of < 1.5 mg% and SGOT (AST) < 2X the upper
limits of normal; adequate renal function defined as serum creatinine clearance > 40
cc/min (measured or calculated).
- Patients must be >= 18 years old.
- Patients may have received oral EMP or no more than one cytotoxic therapy.
- Patients must sign a written informed consent form prior to treatment.
- Patients with severe intercurrent infection.
- Patients with prior exposure to Taxol.
- Patients whose tumors contain small cell or sarcomatoid elements.
- Patients with evidence of conduction block or active myocardial ischemia on ECG.
- Patients with a history of prior malignancy (except noninvasive cutaneous carcinoma).
- Patients with a history of thromboembolism.