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 18 and over NCI UCCRC-7889 NCI-T95-0074H, T95-0074

Objectives

I.  Determine the PSA and objective response rate in patients with 
hormone-refractory prostate cancer treated with oral trimethylcolchicinic acid 
(TMCA) for 4 consecutive days.

II.  Characterize the toxicity of TMCA.

III.  Determine duration of response, time to progression, and survival of 
these patients.

IV.  Characterize further the pharmacokinetics of TMCA.

Entry Criteria

Disease Characteristics:

Histologically documented adenocarcinoma of the prostate

Progressive systemic disease despite at least one endocrine manipulation,
including either orchiectomy or luteinizing hormone-releasing hormone (LHRH)
analogues with or without antiandrogens
  Progressive disease defined by any of the following:
     Progressive symptoms with lesions on bone scan, radiograph, or physical
     exam

     25% increase in perpendicular diameters of a measurable lesion

     Appearance of at least 2 new lesions on x-ray or bone scan

     Prostate-specific antigen (PSA) at least twice normal (4 ng/mL) and
     rising on at least 2 consecutive measurements at least 1 week apart
        Either no decrease in or 2 consecutive increases in PSA after
        discontinuation of flutamide

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  At least 3 weeks since hormonal therapy except LHRH agonist
  Diethylstilbestrol discontinued at least 1 month prior to entry
     Bilateral orchiectomy or LHRH analogue required at discontinuation
  At least 3 weeks since exogenous corticosteroids except for physiologic
     replacement based on corticotropin stimulation test

Radiotherapy:
  At least 3 weeks since radiotherapy

Surgery:
  At least 3 weeks since major surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  CALGB 0-2

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000
  Hemoglobin at least 9 g/dL

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  AST no greater than 4 times normal

Renal:
  Creatinine no greater than 2.0 mg/dL

Other:
  No active acute infection
  No second malignancy within 5 years except:
     Curatively treated nonmelanomatous skin cancer
     Curatively treated stage Ta bladder cancer
  No other serious major illness that would compromise study

Expected Enrollment

Up to 40 PSA-evaluable patients will be entered over 12 months; if fewer than 
3 of the first 20 patients have a PSA response, the study will be closed.  If 
more than 7 of the first 20 patients or at least 8 of 40 patients have a PSA 
response, up to 40 patients with measurable disease will be accrued; if no CR 
or PR is seen in the first 14 patients, the study will close.

Outline

Single-Agent Chemotherapy.  Trimethylcolchicinic acid, TMCA, NSC-36354.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

John Kugler, MD, Protocol chair		Ph: 309-243-3605 Email: jkugler@ohaci.com