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MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
This study is ongoing, but not recruiting participants.
Study NCT00027781   Information provided by National Cancer Institute (NCI)
First Received: December 7, 2001   Last Updated: February 17, 2009   History of Changes

December 7, 2001
February 17, 2009
August 2001
 
 
 
Complete list of historical versions of study NCT00027781 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

Phase II
Interventional
Treatment
Prostate Cancer
Drug: sabarubicin
 
Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. Epub 2005 Dec 7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Israel,   Spain,   Switzerland
 
NCT00027781
 
CDR0000069067, EORTC-16006-30005, MAC-07
European Organization for Research and Treatment of Cancer
 
Study Chair: Walter Fiedler, MD Universitätsklinikum Hamburg-Eppendorf
National Cancer Institute (NCI)
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP