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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00027781
First received: December 7, 2001
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: sabarubicin
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 37
Study Start Date: August 2001
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027781

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
France
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
Germany
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Israel
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel, 49100
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Inselspital, Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Walter Fiedler, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00027781     History of Changes
Other Study ID Numbers: EORTC-16006-30005, EORTC-16006-30005, MAC-07
Study First Received: December 7, 2001
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014