Prostate CancerPhase 2NCT00085228
Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
A Phase 2 study testing oblimersen sodium and docetaxel in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- oblimersen sodium and docetaxel
- How many people
- 116 participants
- Where
- 16 sitesin 11 countries
- Study dates
- Apr 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 11 countries.
16 sites in 11 countries
Belgium5 sites
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, B-9300
Institut Jules Bordet
Brussels, 1000
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, B-9000
U.Z. Gasthuisberg
Leuven, B-3000
United Kingdom2 sites
Western Infirmary
Glasgow, Scotland, G11 6NT
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Denmark1 site
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Netherlands1 site
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- oblimersen sodium, docetaxel
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oblimersen sodiumBiological
docetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
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
Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startApr 2004
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cora N. Sternberg, MD, FACP, Study chair, Azienda Ospedaliera S. Camillo-Forlanini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085228
- Sponsor's protocol ID
- EORTC-30021
- Other IDs
- EORTC-30021, AVENTIS-AVE3139E/2501
- Status last verified
- Sep 2012
- First submitted
- 10 Jun 2004
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Sternberg 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.
PubMed 19297314Sternberg 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00085228
- Acronym / sponsor ID
- EORTC-30021
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 2004
- Primary completion
- Jan 2006 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oblimersen sodium | Biological | – |
| docetaxel | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 19297314Sternberg 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.
- Results publicationSternberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cora N. Sternberg, MD, FACP study chair
Azienda Ospedaliera S. Camillo-Forlanini
16 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oblimersen sodium and docetaxel in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Belgium, United Kingdom, Austria, Denmark, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00085228, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.