Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00085228
Enrollment
116
Registered
2004-06-11
Start date
2004-04-30
Completion date
Unknown
Last updated
2012-09-24

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

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALoblimersen sodium
DRUGdocetaxel

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses

Secondary

MeasureTime frame
Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
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
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
Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death

Countries

Austria, Belgium, Denmark, France, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026