BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016965
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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 advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: ixabepilone Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Start Date : July 2001
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Adult

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.5 mg/dL


  • No recent myocardial infarction, unstable angina, or life-threatening arrhythmia


  • 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


Biologic therapy:

  • No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer
  • No concurrent anticancer immunotherapy


  • 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


  • 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


  • At least 2 weeks since prior surgery for pancreatic cancer and recovered


  • No other concurrent anticancer therapy
  • No concurrent herbal or unconventional therapy (e.g., St. John's Wort)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016965

  Show 95 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert P. Whitehead, MD University of Texas

Publications of Results: Identifier: NCT00016965     History of Changes
Other Study ID Numbers: CDR0000068636
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: April 2003

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases