Prostatic DiseasesPhase 2NCT00672009
A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
A Phase 2 study testing Ixabepilone in people with Prostatic Diseases and Genital Neoplasms, Male, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms
- What is being tested?
- Ixabepilone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2012
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically-confirmed localized prostate cancer
- Predicted probability of recurrence >/= 30% as defined by the updated Kattan nomogram
- Pathologic material available for gene expression analysis including cancer present in 2 or more cores and availability of unstained slides or formalin-fixed paraffin embedded tissue blocks.
- No prior prostate cancer therapy (including hormonal, chemotherapy, radiation or surgery)
- Subjects must be considered as candidates for radical prostatectomy
- EGOG status
Show all 13Show fewer
- Men of child-bearing potential are required to use an effective means of contraception
- Required Initial Laboratory Values:
- ANC >/= 1500/uL
- Platelet Count >/= 100000/uL
- Creatinine Bilirubin AST < 2.5 X ULN
- ALT < 2.5 X ULN
- Hemoglobin >/= 9.0 g/dL
Who cannot join
- A history of significant ventricular arrhythmias
- Neuropathy (> grade 1)
- Recent (within 6 months) myocardial infarction, congestive heart failure, transient ischemic attack or stroke
- Active angina, including active stable and unstable angina
- Acute deep venous thrombosis and/or pulmonary embolism in the past 6 months
- Any prior hormonal therapy including the use of PC Spes or estrogen containing nutriceuticals
Show all 14Show fewer
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma.
- Patients with malignancy diagnosed more than 5 years ago and are disease free for at least 5 years are not excluded.
- Recent (within 4 weeks) surgery or incomplete healing from surgery
- Known history of hypersensitivity reaction to a drug formulated in Cremophor EL
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment
- Active infection requiring antibiotic therapy, or serious intercurrent illness.
- Any other major illness that in the investigators judgment will substantially increase the risk associated with the subject's participation in this study.
- Unwillingness or inability to comply with procedures required in this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery.
Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure.
Read more
Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials.
This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer.
The study has three phases: Screening, Treatment and Follow-up
- Screening: Eligibility will be verified
- Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery
- Follow up: Subjects will be followed every 6 months for up to 5 years.
In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.
- Conditions
- Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Adenocarcinoma, Prostatic Neoplasms
- Being tested
- Ixabepilone
- Keywords
- prostate cancer, radical prostatectomy, ixabepilone
- Medical subject headings
- Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Adenocarcinoma, Prostatic Neoplasms, Neoplasms, Glandular and Epithelial, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called BMS-247550
Ixabepilone 35 mg/m^2 intravenously over 3 hours every 21 days for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Not described Receives: Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the biochemical response rate (defined as >/= 50% reduction in PSA from baseline to the post-therapy value) for non-castrate patients with localized prostate cancer and a >/= 30% risk of recurrence within 5 years.
Measured: 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionAug 2012
Why it stopped: The sponsor terminated funding for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic DiseasesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Mitchell Gross, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Mitchell E Gross, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672009
- Sponsor's protocol ID
- 13963
- Status last verified
- Oct 2018
- First submitted
- 1 May 2008
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00672009
- Acronym / sponsor ID
- 13963
- Conditions
- Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Adenocarcinoma, Prostatic Neoplasms
- Keywords
- prostate cancer, radical prostatectomy, ixabepilone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor terminated funding for the study.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 May 2008 (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.
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery.
Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure.
Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials.
This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer.
The study has three phases: Screening, Treatment and Follow-up
- Screening: Eligibility will be verified
- Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery
- Follow up: Subjects will be followed every 6 months for up to 5 years.
In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Drug: Ixabepilone |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically-confirmed localized prostate cancer
- Predicted probability of recurrence >/= 30% as defined by the updated Kattan nomogram
- Pathologic material available for gene expression analysis including cancer present in 2 or more cores and availability of unstained slides or formalin-fixed paraffin embedded tissue blocks.
- No prior prostate cancer therapy (including hormonal, chemotherapy, radiation or surgery)
- Subjects must be considered as candidates for radical prostatectomy
Key exclusion criteria (14 listed)
- A history of significant ventricular arrhythmias
- Neuropathy (> grade 1)
- Recent (within 6 months) myocardial infarction, congestive heart failure, transient ischemic attack or stroke
- Active angina, including active stable and unstable angina
- Acute deep venous thrombosis and/or pulmonary embolism in the past 6 months
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 |
|---|---|---|
| IxabepiloneAlso: BMS-247550Ixabepilone 35 mg/m^2 intravenously over 3 hours every 21 days for 4 cycles. | Drug | One |
Primary outcome
To determine the biochemical response rate (defined as >/= 50% reduction in PSA from baseline to the post-therapy value) for non-castrate patients with localized prostate cancer and a >/= 30% risk of recurrence within 5 years.
Time frame: 4 cycles
Results and safety
The study was stopped early (reason given: The sponsor terminated funding for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
Related trials for Prostatic Diseases
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Mitchell E Gross, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone in people with Prostatic Diseases and Genital Neoplasms, Male, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. 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: stopped early, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: The sponsor terminated funding for the study.). Results are not available in the source record.
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?
To determine the biochemical response rate (defined as >/= 50% reduction in PSA from baseline to the post-therapy value) for non-castrate patients with localized prostate cancer and a >/= 30% risk of recurrence within 5 years. (time frame: 4 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2018.