Completed

Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare the activity of docetaxel with or without oblimersen, in terms of prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma of the prostate. * Compare the toxicity of these regimens in these patients. Secondary * Compare the time to progression in patients treated with these regimens. * Compare survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, metastatic disease (M0 vs M1 with non-measurable lesions only vs M1 with measurable lesions), prior estramustine (yes vs no), and prior bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV continuously on days 1-7. * Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until progressive disease and then every 16 weeks thereafter. PROJECTED ACCRUAL: A total of 102 patients (51 per treatment arm) will be accrued for this study.

Official TitleRandomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer 
NCT00085228
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Hormone-refractory disease * Disease progression after prior hormonal therapy with luteinizing hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens (given together or consecutively) * Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value * Must demonstrate continued PSA elevation for at least 6 weeks after discontinuation of antiandrogen therapy * PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week * Testosterone ≤ 0.5 ng/mL\* NOTE: \*Patients with medical castration with LH-RH analogue must continue with LH-RH analogue throughout the study * No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides * Other bone metastases allowed * No clinical evidence of brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,500/mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ ULN * PTT and PT ≤ 1.5 times ULN OR * INR ≤ 1.3 Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Cardiovascular * No unstable angina * No uncontrolled hypertension * No deep venous thrombosis within the past 6 months * No cerebrovascular accident, transient ischemic attack, or myocardial infarction within the past 6 months Pulmonary * No pulmonary embolism * No history of interstitial pneumonitis * No history of pulmonary fibrosis Other * Adequate venous access * HIV negative * No active infection * No pre-existing neuropathy * No hypersensitivity to phosphorothioates * No hypersensitivity to oligonucleotides or any other component of the oblimersen formulation or to drugs formulated with polysorbate * No psychological, familial, sociological, or geographical condition that would preclude study compliance * No other malignancy within the past 5 years except adequately treated superficial urothelial or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior estramustine allowed * No other prior chemotherapy * No concurrent estramustine Endocrine therapy * See Disease Characteristics * At least 6 weeks since prior flutamide, bicalutamide, or nilutamide * More than 6 weeks since prior hormonal manipulation with PC-SPES * Concurrent LH-RH agonist allowed * No concurrent antiandrogens Radiotherapy * See Disease Characteristics * No prior radiotherapy involving \> 25% of marrow-producing area * No prior bone-seeking radionuclides * No concurrent radiotherapy (including palliative therapy for painful bone metastases) * No concurrent bone-seeking radionuclides Surgery * See Disease Characteristics Other * Prior bisphosphonates allowed * No concurrent anticoagulation except for low-dose warfarin (1 mg/day) * No concurrent regular (daily) intake of opioid analgesics * No other concurrent experimental drugs or anticancer drugs * No concurrent bisphosphonates

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Suspended

Kaiser Franz Josef Hospital

Vienna, AustriaSee the location
Suspended

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, Belgium
Suspended

Institut Jules Bordet

Brussels, Belgium
Suspended

Cliniques Universitaires Saint-Luc

Brussels, Belgium
Completed16 Study Centers