BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
NCT ID: NCT00016965
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-07-31
2006-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced pancreatic cancer.
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Detailed Description
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* Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550.
* Determine the frequency and severity of toxic effects of this drug in these patients.
* Determine the complete and partial response in those patients with measurable disease treated with this drug.
* Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 6 months for 2 years and then annually until 3 years after registration.
PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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ixabepilone
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed advanced pancreatic adenocarcinoma
* Distant metastases OR
* Locoregional disease that has failed or is not amenable to locoregional therapy
* No de novo locoregional disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* Adult
Performance status:
* Zubrod 0-1
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 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
* Alkaline phosphatase less than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No recent myocardial infarction, unstable angina, or life-threatening arrhythmia
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission
* No prior severe hypersensitivity reaction to drugs containing Cremophor EL
* No active or uncontrolled infection
* No severe psychiatric disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer
* No concurrent anticancer immunotherapy
Chemotherapy:
* No prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* No prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer
* No concurrent anticancer hormonal therapy
Radiotherapy:
* No prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer
* Prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy
* No concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites
Surgery:
* At least 2 weeks since prior surgery for pancreatic cancer and recovered
Other:
* No other concurrent anticancer therapy
* No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Principal Investigators
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Robert P. Whitehead, MD
Role: STUDY_CHAIR
University of Texas
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Genesis Medical Center
Davenport, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Oregon Cancer Institute
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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References
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Whitehead RP, McCoy S, Rivkin SE, Gross HM, Conrad ME, Doolittle GC, Wolff RA, Goodwin JW, Dakhil SR, Abbruzzese JL. A Phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Nov;24(6):515-20. doi: 10.1007/s10637-006-8440-x.
Other Identifiers
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SWOG-S0107
Identifier Type: -
Identifier Source: secondary_id
CDR0000068636
Identifier Type: -
Identifier Source: org_study_id
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