men-10755 in treating patients with progressive prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed hormone-refractory adenocarcinoma of the prostate * disease progression while on prior luteinizing hormone-releasing hormone (lhrh) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively * disease progression is defined as psa progression documented by increases in psa recorded at 2 consecutive measurements over a prior reference value * interval of at least 1 week between the reference value and the first of these two psa increases * continued elevation of psa for at least 6 weeks after discontinuation of antiandrogens * last psa value at least 5 ng/ml (hybritech equivalent) * must have serum testosterone less than 50 ng/ml and must continue on lhrh agonist therapy if no prior surgical castration * no symptomatic brain or leptomeningeal metastatic disease patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * alt/ast no greater than 2.5 times uln (5 times uln if liver metastases present) renal: * creatinine no greater than 1.7 mg/dl * no uncontrolled hypercalcemia cardiovascular: * no history of severe heart disease * no myocardial infarction within the past 6 months * no cardiac insufficiency * normal cardiac function by muga scan and 12-lead ekg other: * no other prior or concurrent malignancy except basal cell or squamous cell skin cancer * no uncontrolled systemic nonmalignant disease or infection * no psychological, familial, or geographical conditions that would preclude compliance prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 4 weeks since prior chemotherapy endocrine therapy: * see disease characteristics * no prior hormonal therapy except estramustine * no concurrent estramustine radiotherapy: * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy (e.g., for painful bone metastases) surgery: * see disease characteristics other: * no other concurrent experimental drugs or investigational therapy

Keywords: adenocarcinoma of the prostate recurrent prostate cancer