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

Alternate Title

Exisulind in Treating Patients to Prevent the Recurrence of Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention, Treatment Closed 18 and over Pharmaceutical / Industry UCLA-HSPC-971104401 CELLPATH-012, NCI-V98-1405

Objectives

I.  Determine the efficacy of sulindac sulfone (FGN-1) in preventing the 
recurrence of prostate cancer in patients who have undergone radical 
prostatectomy and who have increasing PSA levels.

II.  Determine the safety of FGN-1 in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven prostate cancer, for which a radical prostatectomy was
performed

Elevated PSA levels (0.4 ng/mL to 15 ng/mL)
 At least 10% increase in PSA within last 4 months

No evidence of skeletal or other metastasis

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 No androgen deprivation therapy during post-operative period

Radiotherapy:
 At least 6 months since prior radiation therapy
 Cumulative radiation dose no greater than 3000 rads

Surgery:
 See Disease Characteristics

Other:
 No investigational medication or device within one month of study
 At least 2 weeks since nonsteroidal anti-inflammatory drugs (NSAIDs) or
  salicylates
 No concurrent NSAIDs or salicylates
 Low-dose aspirin (less than 3250 mg/month) for cardiovascular prevention may
  be allowed
 At least 3 months since sulindac taken on a regular basis
 No concurrent sulindac

Patient Characteristics:

Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Platelet count at least 100,000/mm3
 Hemoglobin at least 10 g/dL
 No hematologic dysfunction

Hepatic:
 Bilirubin no greater than upper limit of normal (ULN)
 Alkaline phosphatase no greater than ULN
 AST or ALT no greater than ULN
 No hepatic dysfunction

Renal:
 No biliary tract or renal dysfunction

Gastrointestinal:
 No active peptic ulcer disease
 No gastrointestinal problems that will affect absorption (including chronic
  use of antacids)

Other:
 No known hypersensitivity to sulindac
 No other malignancy within past 10 years except nonmelanomatous skin cancer
 No history of alcohol or drug abuse within past 3 years

Expected Enrollment

A total of 90 patients will be accrued for this study.

Outline

This is a randomized, double blind, placebo controlled, multicenter study.

Patients are randomized to receive oral sulindac sulfone (FGN-1) or placebo 2 
times daily for up to 12 months.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Diane Prager, MD, Protocol chair(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719