Status:
COMPLETED
Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
Lead Sponsor:
St. Bartholomew's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
OBJECTIVES: Primary * Compare the prostate-specific antigen (PSA) response in patients with locally advanced or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs imme...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00316927
Start Date
December 1 2002
End Date
April 1 2007
Last Update
June 26 2013
Active Locations (15)
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1
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
2
Burnley General Hospital
Burnley, England, United Kingdom, BB10 2PQ
3
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 3NG
4
Eastbourne District General Hospital
Eastbourne, England, United Kingdom, BN21 2UD