Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given together with two different schedules of diethylstilbestrol to compare how well they work in treating patients with locally advanced or metastatic prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Bartholomew's Hospital
• Treatments: Aspirin; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diethylstilbestrol; Fosfestrol

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of adenocarcinoma of the prostate

• Elevated prostate-specific antigen (PSA)

• Failed previous treatments, including gonadatropan regulatory hormone analogue therapy, radiotherapy, surgery, or any combination of these

• Biochemically castrate (testosterone < 1 nmol/L) at baseline

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months

• ECOG performance status 0-3

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count (neutrophils and bands) ≥ 2,000/mm^3

• Platelet count ≥ 50,000/mm^3

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• AST or ALT ≤ 3 times ULN

• Creatinine ≤ 1.5 times ULN

• Able to swallow tablets

• No other malignancy within the past 3 years except basal cell skin cancer

• No previous thromboembolic disease, including stroke, venous or arterial thrombosis, and myocardial infarction with ongoing angina pectoris

• Prior uncomplicated myocardial infarction allowed

• No diabetes mellitus if treatment titration is thought to be difficult or inappropriate

• No active gastric or duodenal ulcer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior concurrent bisphosphonates allowed

• No concurrent investigational agents or participation in another investigational drug study

• No other concurrent antineoplastic therapy, including new estrogen therapy, radiation therapy, or PC-SPES

• No other concurrent corticosteroids (e.g., dexamethasone for nausea or vomiting) except those prescribed in the study regimen