Prostate Cancer Clinical Trial
Official title:
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who
have progressive prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
- Assess the activity of MEN-10755 in patients with progressive hormone-refractory
adenocarcinoma of the prostate.
- Determine the rate and duration of objective PSA response in patients treated with this
drug.
- Determine the clinical response rate in patients with measurable disease treated with
this drug.
- Determine the acute side effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over
30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence
of disease progression or unacceptable toxicity. Patients who achieve a complete or partial
response continue to receive additional courses. Patients who achieve stable disease may
receive more than 4 courses at the discretion of the investigator.
Patients are followed every 6 weeks until disease progression or initiation of a new
therapy.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
;
Primary Purpose: Treatment
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