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

December 7, 2001
July 23, 2012
August 2001
March 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00027781 on ClinicalTrials.gov Archive Site
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Not Provided
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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.

Interventional
Phase 2
Primary Purpose: Treatment
Prostate Cancer
Drug: sabarubicin
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
Not Provided
March 2003   (final data collection date for primary outcome measure)

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
France,   Spain,   Switzerland,   Israel,   Germany,   Belgium
 
NCT00027781
EORTC-16006-30005, EORTC-16006-30005, MAC-07
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Walter Fiedler, MD Universitätsklinikum Hamburg-Eppendorf
European Organisation for Research and Treatment of Cancer - EORTC
July 2012

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