Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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

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: 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

Relevance to patient case: not relevant