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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: sabarubicin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00027781

MAC-07

EORTC-16006-30005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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