Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI NCI-91-C-200B NCI-CPB-274, NCI-T91-0120N, T91-0120

Objectives

I.  Determine the MTD of somatuline in combination with suramin in patients 
with metastatic androgen-resistant prostate cancer.

II.  Determine the endocrinologic consequences of this therapy.

III.  Provide a pharmacodynamic profile of the drug effect.

Entry Criteria

Disease Characteristics:

Histologically confirmed prostate cancer

Evidence of metastatic disease (elevation of PSA is not
sufficient evidence of metastatic disease unless over 20
ng/ml following prostatectomy or prostate irradiation)

Treatment failure of previous castration (medical or
surgical) and adrenal blockade

No intracranial metastases

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior suramin therapy
  At least 4 weeks since prior systemic therapy
  Complete recovery from prior therapy required

Endocrine therapy:
  No prior somatostatin analogue therapy
  At least 4 weeks since prior systemic therapy
  Complete recovery from prior therapy required

Radiotherapy:
  Complete recovery from prior therapy required

Surgery:
  Complete recovery from prior therapy required

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 80-100%

Life expectancy:
  More than 3 months
  Non-oncologic life expectancy more than 1 year

Hematopoietic:
  WBC more than 4,000
  Platelets more than 150,000
  Hb more than 9.5 g/dl (with no transfusion in prior month)

Hepatic:
  Bilirubin normal
  SGPT no more than 1.25 x normal

Renal:
  Creatinine clearance at least 60 ml/min
  24-hour urinary protein excretion less than 300 mg (or
     negative protein on routine urinalysis)

Other:
  No underlying illness that may be exacerbated by suramin
  therapy or confused with suramin toxicity, e.g.:
     No ongoing infection
     No significant coagulopathy
     No bleeding diathesis
     No nephrotic syndrome
     No multiple sclerosis
  No recent significant bleeding
  No history of hemorrhagic stroke
  No externally draining urinary catheter
  No local cancer complication requiring urgent therapy (such
     as renal obstruction or cord compression)
  Capable of maintaining 2 infusion pumps and an indwelling
     central venous catheter

Expected Enrollment

At least 3 patients will be entered at each dose studied until the MTD is 
established.

Outline

Nonrandomized study.

Growth Factor Antagonist Therapy with Single-agent Chemotherapy and Hormone 
Therapy.  Suramin, SUR, NSC-34936; with Somatuline; and Flutamide, FLUT, 
NSC-147834; with (as indicated) Leuprolide, LEUP, NSC-377526.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

A. Sartor, MD, Protocol chair(Contact information may not be current)		Ph: 504-568-5148