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

NCT ID: NCT00027781

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

sabarubicin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Fiedler, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Locations

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Institut Bergonie

Bordeaux, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, , France

CHU de la Timone

Marseille, , France

CHU Pitie-Salpetriere

Paris, , France

Universitaets-Krankenhaus Eppendorf

Hamburg, , Germany

Rabin Medical Center - Beilinson Campus

Petah Tikva, , Israel

Hospital Universitario 12 de Octubre

Madrid, , Spain

Inselspital, Bern

Bern, , Switzerland

Countries

Belgium; France; Germany; Israel; Spain; Switzerland

References

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.

Reference Type: RESULT

PMID: 16337787 (View on PubMed)

Other Identifiers

EORTC-16006-30005

Identifier Type: -

Identifier Source: secondary_id

MAC-07

Identifier Type: -

Identifier Source: secondary_id

EORTC-16006-30005

Identifier Type: -

Identifier Source: org_study_id