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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sabarubicin
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Antwerpen
  • Institut Bergonie
  • Centre Jean Perrin
  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
  • CHU de la Timone
  • CHU Pitie-Salpetriere
  • Universitaets-Krankenhaus Eppendorf
  • Rabin Medical Center - Beilinson Campus
  • Hospital Universitario 12 de Octubre
  • Inselspital, Bern

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
July 23, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00027781
Brief Title
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sabarubicin

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Fiedler, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Universitaets-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Rabin Medical Center - Beilinson Campus
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16337787
Citation
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. doi: 10.1016/j.ejca.2005.07.030. Epub 2005 Dec 7.
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MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

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