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
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, see Learn About Clinical Studies.

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 August 26, 2014