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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
37
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Institut Bergonie
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, France
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU de la Timone
Marseille, France
CHU Pitie-Salpetriere
Paris, France
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany
Rabin Medical Center - Beilinson Campus
Petah Tikva, Israel
Hospital Universitario 12 de Octubre
Madrid, Spain
Inselspital, Bern
Bern, Switzerland