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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002027-13-GB

Enrollment

Registered

2005-06-21

Start date

2005-07-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone refractory prostate cancer

Interventions

Trade Name: taxotere Product Name: docetaxel Product Code: docetaxel Pharmaceutical Form: Concentrate for solution for infusion Trade N

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Histologically, cytologically or biochemically proven prostate adenocarcinoma. • Serum testosterone 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

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 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

Design outcomes

Primary

Measure	Time frame
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. 2. To evaluate the efficacy of docetaxel plus prednisolone plus diethylstilbestrol plus aspirin in patients with androgen-independent prostate cancer. ;Secondary Objective: To study the effect of concomitant diethylstilbestrol plus aspirin on docetaxel pharmacokinetics.; Primary end point(s): • Phase I: Definition of dose for phase II • Phase II: PSA response rate using the PSAWG criteria	—

Measure

Time frame

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. 2. To evaluate the efficacy of docetaxel plus prednisolone plus diethylstilbestrol plus aspirin in patients with androgen-independent prostate cancer. ;Secondary Objective: To study the effect of concomitant diethylstilbestrol plus aspirin on docetaxel pharmacokinetics.; Primary end point(s): • Phase I: Definition of dose for phase II • Phase II: PSA response rate using the PSAWG criteria

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026