Clinical trial · Interventional
Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
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
NCT00085228CI-TRIAL-00008110completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
- measure
- Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses
Secondary outcomes (4)
- measure
- Time to progression as measured by RECIST and Bubley criteria every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- measure
- Toxicity as measured by CTCAE v3.0 every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- measure
- Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- measure
- Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17. PMID 19297314
- RESULTSternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.