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

Prostate Cancer Clinical Trial

Official title:

Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027781
• Other study ID #: EORTC-16006-30005
• Secondary ID: EORTC-16006-3000
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: July 23, 2012
• Start date: August 2001

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• sabarubicin

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
France	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
Germany	Universitaets-Krankenhaus Eppendorf	Hamburg
Israel	Rabin Medical Center - Beilinson Campus	Petah-Tikva
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  Spain,  Switzerland, 

References & Publications (1)

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 pro — View Citation