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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00027781

Collaborator

(none)

Enrollment

Locations

3.7

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: sabarubicin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitair Ziekenhuis Antwerpen	Edegem	Belgium	B-2650
2	Institut Bergonie	Bordeaux	France	33076
3	Centre Jean Perrin	Clermont-Ferrand	France	63011
4	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon	France	21079
5	CHU de la Timone	Marseille	France	13385
6	CHU Pitie-Salpetriere	Paris	France	75651
7	Universitaets-Krankenhaus Eppendorf	Hamburg	Germany	D-20246
8	Rabin Medical Center - Beilinson Campus	Petah-Tikva	Israel	49100
9	Hospital Universitario 12 de Octubre	Madrid	Spain	28041
10	Inselspital, Bern	Bern	Switzerland	CH-3010

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair: Walter Fiedler, MD, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

European Organisation for Research and Treatment of Cancer - EORTC

ClinicalTrials.gov Identifier:

NCT00027781

Other Study ID Numbers:

EORTC-16006-30005
EORTC-16006-30005
MAC-07

First Posted:

Jan 27, 2003

Last Update Posted:

Jul 24, 2012

Last Verified:

Jul 1, 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC

adenocarcinoma of the prostate

recurrent prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jul 24, 2012