Prostate CancerPhase 2NCT00016393
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase 2 study testing ixabepilone in people with Prostate Cancer, run by SWOG Cancer Research Network at 28 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ixabepilone
- How many people
- Not given
- Where
- 28 sitesUnited States
- Study dates
- Jun 2001to Apr 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)
- Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:
- Progression of unidimensionally measurable lesion outside of a prior radiation port
- Progression of non-measurable disease (e.g., bone scan)
- Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart
- PSA at least 5 ng/mL
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT or SGPT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 40 mL/min
Other:
- No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission
- No other concurrent significant active illness that would preclude study participation
- Recovered from major infections
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 28 days since prior biologic therapy and recovered
- No more than 1 prior biologic (non-cytotoxic) therapy
- No concurrent biological response modifiers
Chemotherapy:
- No prior chemotherapy for this disease
- No other concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 28 days since prior flutamide or ketoconazole
- At least 42 days since prior bicalutamide or nilutamide
- No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy to less than 30% of bone marrow allowed
- No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
- At least 28 days since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- Recovered from prior surgery
- Prior orchiectomy allowed
Other:
- No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)
- Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Harrington Cancer Center
Amarillo, Texas, 79106
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0330
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
University of Kansas Medical Center
Kansas City, Kansas, 66160-7390
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Oregon Cancer Institute
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
University of California Davis Cancer Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES:
- Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer.
- Determine the overall survival and progression-free survival rate in patients treated with this drug.
- Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
- Conditions
- Prostate Cancer
- Being tested
- ixabepilone
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent 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.
ixabepiloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 SWOG Cancer Research NetworkThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Maha Hadi A. Hussain, MD, Study chair, University of Michigan Rogel Cancer CenterPrimo N. Lara, MD, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016393
- Sponsor's protocol ID
- CDR0000068629
- Other IDs
- SWOG-S0111
- Status last verified
- Feb 2004
- First submitted
- 6 May 2001
- Last updated
- 24 Jun 2013
- Results posted
- No
Publications
Hussain M, Tangen CM, Lara PN Jr, Vaishampayan UN, Petrylak DP, Colevas AD, Sakr WA, Crawford ED; Southwest Oncology Group. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005 Dec 1;23(34):8724-9. doi: 10.1200/JCO.2005.02.4448.
PubMed 16314632
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00016393
- Acronym / sponsor ID
- CDR0000068629
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES:
- Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer.
- Determine the overall survival and progression-free survival rate in patients treated with this drug.
- Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| ixabepilone | Drug | – |
Primary outcome
Not reported in the source record.
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 Jun 2013.
- Results publication: PubMed 16314632Hussain M, Tangen CM, Lara PN Jr, Vaishampayan UN, Petrylak DP, Colevas AD, Sakr WA, Crawford ED; Southwest Oncology Group. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005 Dec 1;23(34):8724-9. doi: 10.1200/JCO.2005.02.4448.
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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.
Maha Hadi A. Hussain, MD study chair
University of Michigan Rogel Cancer Center
Primo N. Lara, MD
University of California, Davis
28 sites 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 Prostate Cancer, run by SWOG Cancer Research Network at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00016393, which also lists 1 linked publication.
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 Jun 2013.