MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027781
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: sabarubicin Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 37 participants
Primary Purpose: Treatment
Official Title: Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
Study Start Date : August 2001
Actual Primary Completion Date : March 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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)


  • Creatinine no greater than 1.7 mg/dL
  • No uncontrolled hypercalcemia


  • 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


  • 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


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • No prior hormonal therapy except estramustine
  • No concurrent estramustine


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy (e.g., for painful bone metastases)


  • See Disease Characteristics


  • No other concurrent experimental drugs or investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027781

Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Institut Bergonie
Bordeaux, France, 33076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, France, 21079
CHU de la Timone
Marseille, France, 13385
CHU Pitie-Salpetriere
Paris, France, 75651
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel, 49100
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Inselspital, Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Walter Fiedler, MD Universitätsklinikum Hamburg-Eppendorf

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00027781     History of Changes
Other Study ID Numbers: EORTC-16006-30005
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs