Status:
COMPLETED
Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). Th...
Detailed Description
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 Prostate-Specific Ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00283803
Start Date
March 12 2002
End Date
October 1 2011
Last Update
August 7 2018
Active Locations (1)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109