Trial Information

Summary: A Phase I trial of combined Taxotere/Estramustine + Mitoxantrone/Prednisone in Hormone Refractory Prostate Cancer

Taxotere and Mitoxantrone are given intravenously on the first day of a three week cycle in the outpatient facility of Columbia-Presbyterian Medical Center. Estramustine begins orally one day before the intravenous treatment and continues until four days after. At the present time, we have treated 12 patients and reached a dose level of 45 mg/m2 taxotere and 8/m2 of mitoxantrone. Toxicity has consisted primarily of fatigue, and there has been one episode of neutropenic fever which resolved on intravenous antibiotics, and one TIA in a patient with known carotid artery disease. Glucose intolerance has also been observed, which may be due to the prednisone and the decadron premedication. Many declines in PSA, and an objective response in 1/1 patient have been observed.

To be eligible for this trial, a patient must have adenocarcinoma of the prostate, and must no longer be responding to complete androgen blockade, as demonstrated by a rise in the PSA, or new lesions on bone scan, or a new soft tissue mass. A patient cannot have a history of a clotting disorder, a heart attack within six months, a pulmonary embolus or congestive heart failure. A patient cannot have had any other malignancy in the past five years, except cured skin cancer.

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Trial listings updated: June 1, 2008 at 5:43:13 AM