Evaluation of the Effect of Exisulind on the Duration of the "Off-Treatment" Interval on Patients With Biochemical Relapse of Prostate Cancer Who Are Treated With Intermittent Androgen Suppression


Phase 2
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Evaluation of the Effect of Exisulind on the Duration of the "Off-Treatment" Interval on Patients With Biochemical Relapse of Prostate Cancer Who Are Treated With Intermittent Androgen Suppression


A study doctor will meet with you and ask you about your medical history, examine you, and
explain the study. We will draw some blood for tests (about 4-6 tablespoons), including
PSA. If not already obtained, you will have a bone scan and a CT scan to establish a
baseline.

You will be receiving hormone suppression treatment with monthly injections of an LH-RH
analog such as Lupron or Zoladex and an antiandrogen such as Eulexin or Casodex as part of
your standard care for prostate cancer. About 3 months before your next "off-treatment"
period, you will start 1 Exisulind pill 250 mg (2 x 125mg capsules) by mouth twice a day.
It is necessary for you to start the Exisulind treatment 3 months prior to your next
"off-treatment" period so that the medication can build up in your system enough to be
effective.

Per our standard follow-up procedures, we will ask you to have blood draws every 2 weeks for
up to 12 weeks after starting Exisulind to check liver function. Thereafter you will be
asked to have monthly blood draws, and return to the clinic every 3 months for a physical
examination, to determine how well you are tolerating the study medication, how your cancer
is responding to the treatment, and to give you more study medication. You will continue
taking Exisulind during your "off-treatment" period until your PSA reaches a threshold
level. PSA threshold is defined by your primary treatment. If you have had your prostate
removed, the threshold is 1.0 ng/dL. If you have an intact prostate, your threshold is 4
ng/dL. Once your PSA reaches this level, you will restart your hormone suppression treatment
as directed by your doctor.


Inclusion Criteria:



- A willingness and ability to sign an informed consent document;

- 21 years or of legal age;

- Histologically or cytologically documented prostate cancer.

- ECOG Performance status score of 0 or 1.

- Received at least one cycle of IAS with an LHRH agonist and anti-androgen

- Willingness to remain off chronic NSAIDs (with the exception of ibuprofen or
naproxen), including COX 2 inhibitors and salicylates (e.g., aspirin, mesalamine,
azodisalicylate, salsalate, sulfasalazine) for duration of the study. Patients on
low dose aspirin for cardiovascular prevention may be included in the study.

- Have not taken sulindac (Clinoril™) on regular basis for any indication for one week
prior to enrollment and willing to remain off of sulindac for the duration of the
study.

- Patients with prior radiation must be 2 weeks from their last radiation-treatment and
have recovered from all associated toxicity.

Exclusion Criteria:

- Known hypersensitivity to sulindac (Clinoril™)

- ECOG Performance status score > 1;

- Patients previously on SWOG 9346 or 9921 trials, or any other trials using IAS for
which adding exisulind may be confounding.

- Patients may not have any evidence of hormone-refractory prostate cancer, i.e. 2
consecutive rises in PSA on LHRH agonist and anti-androgen

- Active peptic ulcer disease;

- Use of an investigational medication or device within one month of initiating study
therapy;

- Elevations of serum creatinine to above the upper limit of normal;

- Platelet count < 100,000/L; hgb < 9.0 g/dL; absolute neutrophil count < 1500/mm3

- Known hepatic, biliary tract, renal or hematologic dysfunction which in the opinion
of the Investigator or Sponsor are clinically significant or would obscure laboratory
analyses or are associated with lab abnormalities;

- Any condition or any medication that may interfere with the conduct of the study.

- Bilirubin > ULN. Patients with elevated indirect bilirubin due to Gilbert's Syndrome
will be eligible.

- AST or ALT >2.5 X ULN

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether the addition of exisulind to the treatment of patients who have completed at least ONE cycle of IAS will extend the "off-treatment" cycle.

Outcome Time Frame:

to be determined

Safety Issue:

No

Principal Investigator

Celestia Higano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

01-9710-A04

NCT ID:

NCT00283803

Start Date:

October 2001

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location
Seattle Cancer Care Alliance Seattle, Washington  98109