Trials / Completed
CompletedNCT00027781
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sabarubicin |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2003-03-01
- First posted
- 2003-01-27
- Last updated
- 2012-07-24
Locations
10 sites across 6 countries: Belgium, France, Germany, Israel, Spain, Switzerland
Source: ClinicalTrials.gov record NCT00027781. Inclusion in this directory is not an endorsement.