A phase I/II study of docetaxel plus prednisolone plus diethylstilbestrol plus aspirin in androgen-independent prostate cancer

Phase 1

• Conditions: Hormone refractory prostate cancer

• Registration Number: EUCTR2005-002027-13-GB
• Lead Sponsor: Royal Marsden NHS FOundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 37

Inclusion Criteria

•Histologically, cytologically or biochemically proven prostate adenocarcinoma.
•Serum testosterone < 2 nmol/l. Ongoing androgen deprivation therapy with LHRH analogues or bilateral orchidectomy.
•Progressive disease defined as a PSA rise using 3 serum PSA measurements, each obtained at least 7 days apart within the 3 months prior to start of trial. Patients who were withdrawn from anti-androgen therapy less than 6 weeks prior to inclusion in the study also require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir ? 4 weeks from treatment withdrawal if treated with flutamide and ? 6 weeks if treated with bicalutamide or nilutamide. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
•Life expectancy ? 3 months.
•ECOG performance status 0-2
•Adequate haematological, renal and hepatic function
•Left ventricular ejection fraction > 45%
•Written, informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior cytotoxic chemotherapy, diethylstilbestrol, other oestrogen, estramustine or radioisotope therapy
•Other malignant disease within the previous 5 years, other than adequately treated basal cell carcinoma.
•External beam radiotherapy, brachytherapy or cryotherapy within 6 weeks of start of study.
•Haemoglobin <10.0 g/dl, ANC <1.5 x 109, platelets <100 x 109.
•Bilirubin >ULN, AST >1.5 x ULN, ALT > 1.5 x ULN.
•Patients with serious or uncontrolled co-existent non-malignant diseases. Active or uncontrolled infection.
•History of thrombo-embolic disease
•Aspirin hypersensitivity
•Symptomatic peripheral neuropathy ? grade 2 (NCI CTC)
•Treatment with any investigational compound within 30 days
•Concurrent use of CYP3A4 modulating drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1.To evaluate the safety, tolerability and recommended dose of docetaxel, used in combination with prednisolone 10 mg po od and diethylstilbestrol 1 mg po od and aspirin 75 mg po od in patients with androgen-independent prostate cancer.<br> 2.To evaluate the efficacy of docetaxel plus prednisolone plus diethylstilbestrol plus aspirin in patients with androgen-independent prostate cancer.<br> ;Secondary Objective: To study the effect of concomitant diethylstilbestrol plus aspirin on docetaxel pharmacokinetics.;<br> Primary end point(s): •Phase I: Definition of dose for phase II<br> •Phase II: PSA response rate using the PSAWG criteria<br>