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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed over 18 NCI NCCTG-935251 NCCTG-93-52-51

Objectives

I.  Determine the antitumor activity of ICI D1694 (a thymidylate synthase 
inhibitor) in patients with advanced hormone-refractory prostate cancer.

Entry Criteria

Disease Characteristics:

Histologically confirmed adenocarcinoma of the prostate that is metastatic

Clear evidence of progression despite primary hormonal therapy (e.g.,
bilateral orchiectomy, estrogen, or luteinizing hormone-releasing hormone) by
1 of the following:
  New sites of metastases
  Worsening pain associated with metastatic lesions plus increase in PSA
  Clinical or radiographic worsening of a previously noted lesion with stable
     or rising PSA

If no more than 3 months since discontinuation of flutamide, cyproterone,
bicalutamide, or megestrol, progression documented by 1 of the following:
  2 successive increases in PSA
  New sites of disease

Hormonal therapy with luteinizing hormone-releasing hormone agonists or
estrogens continued throughout study in patients without bilateral orchiectomy

Measurable or evaluable disease required
  Measurable disease defined as:
     Hepatomegaly
     Bidimensional lesion

  Evaluable disease defined as PSA at least 40 ng/mL plus 1 of the following:
     Lesion clearly visible on chest x-ray, CT, or MRI
     Areas of increased uptake on bone scan

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  See Disease Characteristics

Radiotherapy:
  No prior strontium-89
  No prior radiotherapy to greater than 30% of bone marrow (external-beam
     radiotherapy to prostate allowed)
  At least 4 weeks since radiotherapy

Surgery:
  At least 3 weeks since major surgery and recovered

Patient Characteristics:

Age:
  Over 18

Performance status:
  ECOG 0 or 1

Hematopoietic:
  WBC greater than 3,400
  Platelets at least 130,000

Hepatic:
  Bilirubin no greater than 1.5 times normal
  AST no greater than 2.5 times normal

Renal:
  Creatinine normal

Cardiovascular:
  No NYHA class III/IV status

Other:
  Daily caloric intake at least 1,200 kilocalories
  No infection
  No weight loss in the previous 2 months exceeding 10% of current weight
  No second malignancy within 5 years except curatively treated, nonmetastatic
     nonmelanomatous skin cancer

Expected Enrollment

A total of 45 evaluable patients will be treated if there are at least 3 
responses in the first 15 patients and at least 7 responses in the first 30 
patients.  Accrual is anticipated to require 4-9 months.

Outline

Single-Agent Chemotherapy.  ICI D1694, TDX, NSC-639186.
 

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Patrick Burch, MD, Protocol chair		Ph: 507-284-2511 Email: burch.patrick@mayo.edu