Clinical trial NCT00027781: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
city: Marseille
country: France
facility: CHU de la Timone
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Hamburg
country: Germany
facility: Universitaets-Krankenhaus Eppendorf
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Campus
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bern
country: Switzerland
facility: Inselspital, Bern
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Walter Fiedler, MD
role: STUDY_CHAIR
References:
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.